The following data is part of a premarket notification filed by Microtek Medical, Inc. An Ecolab Company with the FDA for Surgical Light Handle Cover.
| Device ID | K133554 |
| 510k Number | K133554 |
| Device Name: | SURGICAL LIGHT HANDLE COVER |
| Classification | Light, Surgical, Accessories |
| Applicant | MICROTEK MEDICAL, INC. AN ECOLAB COMPANY 370 WABASHA STREET N St. Paul, MN 55102 |
| Contact | Andy Roller |
| Correspondent | Andy Roller MICROTEK MEDICAL, INC. AN ECOLAB COMPANY 370 WABASHA STREET N St. Paul, MN 55102 |
| Product Code | FTA |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-19 |
| Decision Date | 2014-04-08 |
| Summary: | summary |