510(k) K073614
K073614 is an FDA 510(k) premarket notification submitted by Foosin Medical Supplies, Inc. for the device "WG-SURGICAL SUTURES WITH NEEDLE". The FDA issued a decision of Substantially Equivalent on April 30, 2008. The device falls under product code NEW (Suture, Surgical, Absorbable, Polydioxanone), a Class II device regulated under 21 CFR 878.4840. Foosin Medical Supplies, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 2008
- Date Received
- December 26, 2007
- 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