The following data is part of a premarket notification filed by Coapt Systems, Inc. with the FDA for Endotine Transbleph 3.0/3.5 Device.
| Device ID | K042796 |
| 510k Number | K042796 |
| Device Name: | ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE |
| Classification | Screw, Fixation, Bone |
| Applicant | COAPT SYSTEMS, INC. 1820 EMBARCADERO RD. Palo Alto, CA 94566 |
| Contact | Bankim Mehta |
| Correspondent | Bankim Mehta COAPT SYSTEMS, INC. 1820 EMBARCADERO RD. Palo Alto, CA 94566 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-07 |
| Decision Date | 2004-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847399006806 | K042796 | 000 |
| 00847399006790 | K042796 | 000 |