FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK
K Number: K946173
·
Decision Jan 9, 1995
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
31
Applicant Total
172
Review Days
21
Basic Information
- Device Name
- STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK
- K Number
- K946173
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4495
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ETHICON, INC.
- Date Received
- December 19, 1994
- Decision Date
- January 9, 1995
- Product Code
- GAQ
- 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 |
|---|---|---|---|
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | FDA class 2 | General, Plastic Surgery |
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