510(k) K143584
K143584 is an FDA 510(k) premarket notification submitted by Resorba Medical GmbH for the device "PGA RESORBA, PGA RESOQUICK, GLYCOLON". The FDA issued a decision of Substantially Equivalent on November 2, 2015. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Resorba Medical GmbH has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 2, 2015
- Date Received
- December 18, 2014
- Clearance Type
- Traditional
- 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