FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
POLYESTER NONABSORBABLE SURGICAL SUTURES USP
K Number: K961925
·
Decision Jul 29, 1996
Classifications
1
FEI Numbers
242
Registration Numbers
242
Same Product Code
173
Applicant Total
5
Review Days
73
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Basic Information
- Device Name
- POLYESTER NONABSORBABLE SURGICAL SUTURES USP
- K Number
- K961925
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5000
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- R. K. Medical L. L. C.
- Date Received
- May 17, 1996
- Decision Date
- July 29, 1996
- Product Code
- GAT
- 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 |
|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | FDA class 2 | General, Plastic Surgery |
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Other Clearances by R. K. Medical L. L. C.
| K Number | Device Name | ||
|---|---|---|---|
| K961931 | PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP | Jul 29, 1996 | Substantially Equivalent |
| K961389 | POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES | Jun 18, 1996 | Substantially Equivalent for Some Indications |
| K960328 | SILK NONABSORBABLE SURGICAL SUTURES USP | Mar 4, 1996 | Substantially Equivalent for Some Indications |
| K960327 | NYLON NOABSORBABLE SURGICAL SUTURES USP | Mar 4, 1996 | Substantially Equivalent for Some Indications |