510(k) K010909
K010909 is an FDA 510(k) premarket notification submitted by Tyco Healthcare Group LP for the device "NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE". The FDA issued a decision of Substantially Equivalent on April 9, 2001. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. Tyco Healthcare Group LP has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 2001
- Date Received
- March 26, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Synthetic, Polypropylene
- Device Class
- Class II
- Regulation Number
- 878.5010
- Review Panel
- SU
- Submission Type