510(k) K903175
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 26, 1991
- Date Received
- July 18, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Synthetic, Polyester
- Device Class
- Class II
- Regulation Number
- 878.5000
- Review Panel
- SU
- Submission Type