The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Totalshield Surgical Helmet System.
| Device ID | K132386 |
| 510k Number | K132386 |
| Device Name: | TOTALSHIELD SURGICAL HELMET SYSTEM |
| Classification | Gown, Surgical |
| Applicant | ZIMMER, INC. 9001 WESLEYAN ROAD, STE 200 Indianapolis, IN 46268 |
| Contact | Allison Scott, Rac |
| Correspondent | Allison Scott, Rac ZIMMER, INC. 9001 WESLEYAN ROAD, STE 200 Indianapolis, IN 46268 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-01 |
| Decision Date | 2013-12-23 |
| Summary: | summary |