FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPORICIDIN BRAND DISINFECTANT TOWELETTES
K Number: K904579
·
Decision May 18, 1992
Classifications
1
FEI Numbers
370
Registration Numbers
370
Same Product Code
72
Applicant Total
8
Review Days
587
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Basic Information
- Device Name
- SPORICIDIN BRAND DISINFECTANT TOWELETTES
- K Number
- K904579
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6890
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Sporicidin Intl.
- Date Received
- October 9, 1990
- Decision Date
- May 18, 1992
- Product Code
- LRJ
- 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 |
|---|---|---|---|
| LRJ | Disinfectant, Medical Devices | FDA class 1 | General Hospital |
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Other Clearances by Sporicidin Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K003087 | MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION | Nov 7, 2000 | Substantially Equivalent |
| 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 |
| K830722 | SPORIDIDIN-D COLD STERILIZING/SOLUTION | Jun 30, 1983 | Substantially Equivalent |