510(k) K063536
K063536 is an FDA 510(k) premarket notification submitted by Tyco Healthcare Group for the device "POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING". The FDA issued a decision of Substantially Equivalent on January 29, 2007. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Tyco Healthcare Group has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 2007
- Date Received
- November 22, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Absorbable, Synthetic, Polyglycolic Acid
- Device Class
- Class II
- Regulation Number
- 878.4493
- Review Panel
- SU
- Submission Type