The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Total Shield Surgical;toga(regular, Large,x-large);hood; Helmet Advanced Helmet W/led Lighting, Total Shield Accessories.
| Device ID | K142166 |
| 510k Number | K142166 |
| Device Name: | TOTAL SHIELD SURGICAL;TOGA(REGULAR, LARGE,X-LARGE);HOOD; HELMET ADVANCED HELMET W/LED LIGHTING, TOTAL SHIELD ACCESSORIES |
| Classification | Gown, Surgical |
| Applicant | ZIMMER, INC. 200 W. OHIO AVE. Dover, OH 44622 |
| Contact | Angela Estrada |
| Correspondent | Angela Estrada ZIMMER, INC. 200 W. OHIO AVE. Dover, OH 44622 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-30 |
| Decision Date | 2014-08-28 |
| Summary: | summary |