The following data is part of a premarket notification filed by Coapt Systems, Inc. with the FDA for Ultratine Forehead.
| Device ID | K060249 |
| 510k Number | K060249 |
| Device Name: | ULTRATINE FOREHEAD |
| Classification | Screw, Fixation, Bone |
| Applicant | COAPT SYSTEMS, INC. 1820 EMBARCADERO RD. Palo Alto, CA 94303 |
| Contact | Linda Ruedy |
| Correspondent | Linda Ruedy 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 | 2006-01-31 |
| Decision Date | 2006-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847399006882 | K060249 | 000 |
| 00847399006875 | K060249 | 000 |