The following data is part of a premarket notification filed by Microtek Medical, Inc. with the FDA for Lesinski Surgical Ear Dressing.
| Device ID | K950906 |
| 510k Number | K950906 |
| Device Name: | LESINSKI SURGICAL EAR DRESSING |
| Classification | Gauze/sponge, Internal |
| Applicant | MICROTEK MEDICAL, INC. 1710 SHELBY OAKS DR., SUITE 21 Memphis, TN 38134 |
| Contact | Raymond G Wallace |
| Correspondent | Raymond G Wallace MICROTEK MEDICAL, INC. 1710 SHELBY OAKS DR., SUITE 21 Memphis, TN 38134 |
| Product Code | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-28 |
| Decision Date | 1995-06-22 |