The following data is part of a premarket notification filed by Microtek Medical, Inc. with the FDA for Microtek Medical Warming Drape.
Device ID | K060200 |
510k Number | K060200 |
Device Name: | MICROTEK MEDICAL WARMING DRAPE |
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 | 2006-01-26 |
Decision Date | 2006-05-31 |
Summary: | summary |