The following data is part of a premarket notification filed by Microbio-medics, Inc. with the FDA for Microtek's Surgical Lamp Handle & Cover.
| Device ID | K901154 |
| 510k Number | K901154 |
| Device Name: | MICROTEK'S SURGICAL LAMP HANDLE & COVER |
| Classification | Light, Surgical, Accessories |
| Applicant | MICROBIO-MEDICS, INC. P.O. BOX 1147 Tucker, GA 30085 |
| Contact | A Smallwood |
| Correspondent | A Smallwood MICROBIO-MEDICS, INC. P.O. BOX 1147 Tucker, GA 30085 |
| Product Code | FTA |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-13 |
| Decision Date | 1990-03-20 |