The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Otomimix.
| Device ID | K042516 |
| 510k Number | K042516 |
| Device Name: | OTOMIMIX |
| Classification | Cement, Ear, Nose And Throat |
| Applicant | WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Contact | Kim Reed |
| Correspondent | Kim Reed WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Product Code | NEA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-16 |
| Decision Date | 2004-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036141943 | K042516 | 000 |
| 00888233025201 | K042516 | 000 |