POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING
FDA 510(k) clearance K063536 · decided 2007-01-29
Clearance details
- K-number
- K063536
- Device name
- POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING
- Applicant
- Tyco Healthcare Group
- Decision
- Substantially Equivalent
- Date received
- 2006-11-22
- Decision date
- 2007-01-29
- Days to decision
- 68 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
- Norwalk, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.