510(k) K003028
CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC by
Osteogenics Biomedical, Inc.
— Product Code NBY
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 24, 2000
- Date Received
- September 28, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
- Device Class
- Class II
- Regulation Number
- 878.5035
- Review Panel
- SU
- Submission Type