BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE
FDA 510(k) clearance K905482 · decided 1991-03-14
Clearance details
- K-number
- K905482
- Device name
- BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE
- Applicant
- Pfizer Hospital Products Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-12-06
- Decision date
- 1991-03-14
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- GAM
- Device class
- 2
- Regulation number
- 878.4493
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Fall River, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Deknatel Bondek Plus Polyglycolic Absorbable Surgical Sutures, Bon+BG BR 3-0 DSL 19 1N (45 recall (Z-2286-2010) | Telefelx Medical | 2010-08-26 |