510(k) K142810
K142810 is an FDA 510(k) premarket notification submitted by Foosin Medical Supplies Inc., Ltd. for the device "WEGO-PGCL Absorbable Surgical Monofilament Suture". The FDA issued a decision of Substantially Equivalent on November 14, 2014. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Foosin Medical Supplies Inc., Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 14, 2014
- Date Received
- September 29, 2014
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Absorbable, Synthetic, Polyglycolic Acid
- Device Class
- Class II
- Regulation Number
- 878.4493
- Review Panel
- SU
- Submission Type