FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT
K Number: K012889
·
Decision May 27, 2003
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
63
Applicant Total
8
Review Days
637
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Basic Information
- Device Name
- BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT
- K Number
- K012889
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6885
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pascal Co., Inc.
- Date Received
- August 28, 2001
- Decision Date
- May 27, 2003
- 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)
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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)
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·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)
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·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
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| K911259 | HYDENT | Jun 6, 1991 | Substantially Equivalent |