510(k) K920421
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- December 13, 1993
- Date Received
- January 31, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Synthetic, Polyethylene
- Device Class
- Class II
- Regulation Number
- 878.5000
- Review Panel
- SU
- Submission Type