510(k) K043591
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 4, 2005
- Date Received
- December 28, 2004
- Clearance Type
- Traditional
- 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