FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TENCEL X-RAY DETECTABLE SPONGES/LAP PADS
K Number: K932846
·
Decision Dec 9, 1993
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
110
Applicant Total
3
Review Days
182
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Basic Information
- Device Name
- TENCEL X-RAY DETECTABLE SPONGES/LAP PADS
- K Number
- K932846
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4450
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Courtaulds Fibers, Inc.
- Date Received
- June 10, 1993
- Decision Date
- December 9, 1993
- Product Code
- GDY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | FDA class 1 | General, Plastic Surgery |
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