The following data is part of a premarket notification filed by Envoy Medical Corporation with the FDA for Envoycem, Model 1640.
| Device ID | K080032 |
| 510k Number | K080032 |
| Device Name: | ENVOYCEM, MODEL 1640 |
| Classification | Cement, Ear, Nose And Throat |
| Applicant | ENVOY MEDICAL CORPORATION 5000 TOWNSHIP PARKWAY Saint Paul, MN 55110 |
| Contact | Bernard (bud) Horwath |
| Correspondent | Bernard (bud) Horwath ENVOY MEDICAL CORPORATION 5000 TOWNSHIP PARKWAY Saint Paul, MN 55110 |
| Product Code | NEA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-07 |
| Decision Date | 2008-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812282020375 | K080032 | 000 |