The following data is part of a premarket notification filed by Coapt Systems, Inc. with the FDA for Vf Gel Plus.
| Device ID | K071663 |
| 510k Number | K071663 |
| Device Name: | VF GEL PLUS |
| Classification | System, Vocal Cord Medialization |
| 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 | MIX |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-18 |
| Decision Date | 2008-02-15 |
| Summary: | summary |