FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
STERI-SWAB
K Number: K912731
·
Decision Oct 2, 1991
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
24
Applicant Total
1
Review Days
104
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Basic Information
- Device Name
- STERI-SWAB
- K Number
- K912731
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Westlock Investments (Usa), Inc.
- Date Received
- June 20, 1991
- Decision Date
- October 2, 1991
- Product Code
- LKB
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LKB | Pad, Alcohol, Device Disinfectant | FDA unclassified | Unknown |
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