510(k) K030351
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 2003
- Date Received
- February 3, 2003
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- Device Class
- Class II
- Regulation Number
- 878.4495
- Review Panel
- SU
- Submission Type