The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Cut Resistant Glove Liner, Xsmall, Small, Medium, Large, Xlarge.
| Device ID | K063582 |
| 510k Number | K063582 |
| Device Name: | ZIMMER CUT RESISTANT GLOVE LINER, XSMALL, SMALL, MEDIUM, LARGE, XLARGE |
| Classification | Surgeon's Gloves |
| Applicant | ZIMMER, INC. 200 WEST OHIO AVENUE P.O. BOX 10 Dover, OH 44622 -0010 |
| Contact | Cindy J Dickey |
| Correspondent | Cindy J Dickey ZIMMER, INC. 200 WEST OHIO AVENUE P.O. BOX 10 Dover, OH 44622 -0010 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-01 |
| Decision Date | 2007-04-26 |
| Summary: | summary |