510(k) K100780
K100780 is an FDA 510(k) premarket notification submitted by Unilene Sac for the device "VITAL SUTURES, SUTUREX, CIRUGIA PERUANA". The FDA issued a decision of Substantially Equivalent on December 14, 2010. The device falls under product code NEW (Suture, Surgical, Absorbable, Polydioxanone), a Class II device regulated under 21 CFR 878.4840. Unilene Sac has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 2010
- Date Received
- March 19, 2010
- Clearance Type
- Traditional
- 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