510(k) K031443
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 18, 2003
- Date Received
- May 6, 2003
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Surgical, Absorbable, Polydioxanone
- Device Class
- Class II
- Regulation Number
- 878.4840
- Review Panel
- SU
- Submission Type