510(k) K032698
K032698 is an FDA 510(k) premarket notification submitted by Coapt Systems, Inc. for the device "COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE". The FDA issued a decision of Substantially Equivalent on October 23, 2003. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Coapt Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 2003
- Date Received
- September 2, 2003
- 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