The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Micro-mitt.
| Device ID | K830821 |
| 510k Number | K830821 |
| Device Name: | MICRO-MITT |
| Classification | Cover, Shoe, Operating-room |
| Applicant | COOPERVISION, INC. PERMALENS HOUSE 1 BOTLEY ROAD, HEDGE END Southampton, GB S033hb |
| Product Code | FXP |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-15 |
| Decision Date | 1983-04-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MICRO-MITT 73385613 1295891 Dead/Cancelled |
Clayman; Henry M. 1982-09-15 |