FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADVANCE SUTURE NONABSORBABLE NYLON SUTURE
K Number: K903177
·
Decision Jun 28, 1991
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
56
Applicant Total
5
Review Days
345
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Basic Information
- Device Name
- ADVANCE SUTURE NONABSORBABLE NYLON SUTURE
- K Number
- K903177
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5020
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Advance Suture, Inc.
- Date Received
- July 18, 1990
- Decision Date
- June 28, 1991
- Product Code
- GAR
- 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 |
|---|---|---|---|
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Advance Suture, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K903175 | ADVANCE SUTURE NONABSORBABLE DACRON SUTURE | Jul 26, 1991 | Substantially Equivalent |
| K903174 | ADVANCE SUTURE ABSORBABLE GUT SUTURE | Jul 10, 1991 | Substantially Equivalent |
| K903176 | ADVANCE SUTURE NONABSORBABLE POLYPROPYLENE SUTURE | Jun 28, 1991 | Substantially Equivalent |
| K905454 | ADVANCE SUTURE NONABSORBABLE SILK SUTURE | Jun 28, 1991 | Substantially Equivalent |