The following data is part of a premarket notification filed by Cytophil, Inc. with the FDA for Renu Gel.
| Device ID | K150400 |
| 510k Number | K150400 |
| Device Name: | Renu Gel |
| Classification | System, Vocal Cord Medialization |
| Applicant | CYTOPHIL, INC. 2485 CORPORATE CIRCLE SUITE 2 East Troy, WI 53120 |
| Contact | Bob Voigts |
| Correspondent | Bob Voigts CYTOPHIL, INC. 2485 CORPORATE CIRCLE SUITE 2 East Troy, WI 53120 |
| Product Code | MIX |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-18 |
| Decision Date | 2015-04-06 |