The following data is part of a premarket notification filed by Coapt Systems, Inc. with the FDA for Coapt Endotine Midface-st 4.5 Device.
| Device ID | K032698 |
| 510k Number | K032698 |
| Device Name: | COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | COAPT SYSTEMS, INC. 1820 EMBARCADERO RD. Palo Alto, CA 94303 |
| Contact | Lori Dondiego |
| Correspondent | Lori Dondiego COAPT SYSTEMS, INC. 1820 EMBARCADERO RD. Palo Alto, CA 94303 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-02 |
| Decision Date | 2003-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847399006783 | K032698 | 000 |