The following data is part of a premarket notification filed by Microtek Medical, Inc. with the FDA for Microtek Equipment Drapes.
| Device ID | K050322 |
| 510k Number | K050322 |
| Device Name: | MICROTEK EQUIPMENT DRAPES |
| Classification | Drape, Surgical |
| Applicant | MICROTEK MEDICAL, INC. 512 LEHMBERG RD. Columbus, MS 39702 |
| Contact | Thomas Bonner |
| Correspondent | Thomas Bonner MICROTEK MEDICAL, INC. 512 LEHMBERG RD. Columbus, MS 39702 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-09 |
| Decision Date | 2005-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902081491 | K050322 | 000 |
| 00841036056032 | K050322 | 000 |