FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUTURE NONABSORBABLE- SILK, POLYESTER
K Number: K932038
·
Decision Jan 7, 1994
Classifications
1
FEI Numbers
242
Registration Numbers
242
Same Product Code
173
Applicant Total
9
Review Days
255
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Basic Information
- Device Name
- SUTURE NONABSORBABLE- SILK, POLYESTER
- K Number
- K932038
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5000
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Surgical Specialties, Inc.
- Date Received
- April 27, 1993
- Decision Date
- January 7, 1994
- 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 Surgical Specialties, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K930826 | SUTURE NONABSORBABLE - SILK | Jan 7, 1994 | Substantially Equivalent |
| K930825 | SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLES | Jan 7, 1994 | Substantially Equivalent |
| K932037 | SUTURE ABSORBABLE- GUT | Jan 7, 1994 | Substantially Equivalent |
| K874219 | S3 MEDICATED GAUZE | Nov 23, 1987 | Substantially Equivalent |
| K861443 | S1 VAGINAL PACKING | May 6, 1986 | Substantially Equivalent |
| K861444 | S1 NASAL PACKING | May 6, 1986 | Substantially Equivalent |
| K861445 | S1 CAVITY PACKING | May 6, 1986 | Substantially Equivalent |
| K861446 | S1 ORAL PACKING | May 6, 1986 | Substantially Equivalent |