The following data is part of a premarket notification filed by Zimmer Surgical, Inc with the FDA for Totalshield Ii Surgical Helmet System.
| Device ID | K192194 |
| 510k Number | K192194 |
| Device Name: | TotalShield II Surgical Helmet System |
| Classification | Gown, Surgical |
| Applicant | Zimmer Surgical, Inc 200 West Ohio Avenue Dover, OH 44622 |
| Contact | Abigail Miller |
| Correspondent | Michael Wolford R&Q Solutions 2790 Mosside Blvd #800 Monroeville, PA 15146 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-13 |
| Decision Date | 2019-10-15 |