The following data is part of a premarket notification filed by Coapt Systems, Inc. with the FDA for Coapt Endotine Chin 3.5 Device.
| Device ID | K033524 |
| 510k Number | K033524 |
| Device Name: | COAPT ENDOTINE CHIN 3.5 DEVICE |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-07 |
| Decision Date | 2003-12-18 |
| Summary: | summary |