The following data is part of a premarket notification filed by Cytophil Inc with the FDA for Vocalis Gel.
| Device ID | K081815 |
| 510k Number | K081815 |
| Device Name: | VOCALIS GEL |
| Classification | System, Vocal Cord Medialization |
| Applicant | CYTOPHIL INC 5546 N SANTA MONICA BLVD Whitefish Bay, WI 53217 -5159 |
| Contact | Greg Johnson |
| Correspondent | Greg Johnson CYTOPHIL INC 5546 N SANTA MONICA BLVD Whitefish Bay, WI 53217 -5159 |
| Product Code | MIX |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-26 |
| Decision Date | 2009-01-05 |
| Summary: | summary |