The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer A.t.s. 3000 Automatic Tourniquet System.
| Device ID | K050411 |
| 510k Number | K050411 |
| Device Name: | ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM |
| Classification | Tourniquet, Pneumatic |
| 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 | KCY |
| CFR Regulation Number | 878.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-17 |
| Decision Date | 2005-09-02 |
| Summary: | summary |