The following data is part of a premarket notification filed by Mednet Locator, Inc. with the FDA for Gold Total And Partial, Regular And Offset, Ossicular Replacement Prostheses, Gold Total With Fountian Head, Gold Piston.
| Device ID | K001404 |
| 510k Number | K001404 |
| Device Name: | GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON |
| Classification | Replacement, Ossicular Prosthesis, Total |
| Applicant | MEDNET LOCATOR, INC. 7000 SHADOW OAKS Memphis, TN 38125 |
| Contact | Judy Chandler |
| Correspondent | Judy Chandler MEDNET LOCATOR, INC. 7000 SHADOW OAKS Memphis, TN 38125 |
| Product Code | ETA |
| CFR Regulation Number | 874.3495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-03 |
| Decision Date | 2000-08-08 |