FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION
K Number: K003087
·
Decision Nov 7, 2000
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
63
Applicant Total
8
Review Days
41
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Basic Information
- Device Name
- MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION
- K Number
- K003087
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6885
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sporicidin Intl.
- Date Received
- September 27, 2000
- Decision Date
- November 7, 2000
- Product Code
- MED
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MED | Sterilant, Medical Devices | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MED), ordered by most recent decision date.
SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
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SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900)
FDA 510(k)
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SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
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SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
FDA 510(k)
FDA Class 2
·General Hospital
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
FDA 510(k)
FDA Class 2
·General Hospital
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Sporicidin Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K983194 | SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (SSDS) | Mar 5, 1999 | Substantially Equivalent |
| K926013 | SPORICIDIN BRAND DISINFECT TOWEL, SPRAY/SOLUT MODI | Feb 12, 1993 | Substantially Equivalent |
| K922262 | SPORICIDIN BRAND DISINFECT TOWELETTES/SPRAY/SOLUT | Sep 15, 1992 | Substantially Equivalent for Some Indications |
| K904581 | SPORICIDIN BRAND DISINFECTANT SOLUTION | May 18, 1992 | Substantially Equivalent |
| K904580 | SPORICIDIN BRAND DISINFECTANT SPRAY | May 18, 1992 | Substantially Equivalent |
| K904579 | SPORICIDIN BRAND DISINFECTANT TOWELETTES | May 18, 1992 | Substantially Equivalent |
| K830722 | SPORIDIDIN-D COLD STERILIZING/SOLUTION | Jun 30, 1983 | Substantially Equivalent |