The following data is part of a premarket notification filed by Cytophil Inc with the FDA for Calcium Hydroxylapatite Vocal Fold Implant.
| Device ID | K121795 |
| 510k Number | K121795 |
| Device Name: | CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT |
| Classification | System, Vocal Cord Medialization |
| Applicant | CYTOPHIL INC 2485 CORPORATE CIRCLE SUITE 2 East Troy, WI 53120 |
| Contact | Bill Hubbard |
| Correspondent | Bill Hubbard CYTOPHIL INC 2485 CORPORATE CIRCLE SUITE 2 East Troy, WI 53120 |
| Product Code | MIX |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-19 |
| Decision Date | 2013-02-22 |
| Summary: | summary |