The following data is part of a premarket notification filed by Gyrus Ent L.l.c. with the FDA for Vocom (vocal Cord Medialization) Implant.
| Device ID | K974311 |
| 510k Number | K974311 |
| Device Name: | VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT |
| Classification | Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) |
| Applicant | GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Contact | Alicia Farage |
| Correspondent | Alicia Farage GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Product Code | KHJ |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-17 |
| Decision Date | 1998-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925021617 | K974311 | 000 |
| 00821925019164 | K974311 | 000 |
| 00821925019171 | K974311 | 000 |
| 00821925019225 | K974311 | 000 |
| 00821925019232 | K974311 | 000 |
| 00821925019249 | K974311 | 000 |
| 00821925019300 | K974311 | 000 |
| 00821925019317 | K974311 | 000 |
| 00821925019324 | K974311 | 000 |
| 00821925019157 | K974311 | 000 |