The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered With Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover.
| Device ID | K200493 |
| 510k Number | K200493 |
| Device Name: | Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered With Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover |
| Classification | Hood, Surgical |
| Applicant | Stryker Corporation 4100 E. Milham Avenue Kalamazoo, MI 49001 |
| Contact | Corinne Larke-grass |
| Correspondent | Corinne Larke-grass Stryker Corporation 4100 E. Milham Avenue Kalamazoo, MI 49001 |
| Product Code | FXY |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-28 |
| Decision Date | 2020-03-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37613327466707 | K200493 | 000 |
| 37613327465977 | K200493 | 000 |
| 37613327465960 | K200493 | 000 |
| 37613327465915 | K200493 | 000 |
| 37613327465908 | K200493 | 000 |
| 37613327465892 | K200493 | 000 |
| 37613327465885 | K200493 | 000 |
| 37613327465861 | K200493 | 000 |
| 37613327465793 | K200493 | 000 |
| 37613327466110 | K200493 | 000 |
| 37613327466035 | K200493 | 000 |
| 37613327465953 | K200493 | 000 |
| 37613327465946 | K200493 | 000 |
| 37613327465984 | K200493 | 000 |
| 37613327465991 | K200493 | 000 |
| 37613327466004 | K200493 | 000 |
| 37613327466684 | K200493 | 000 |
| 37613327466134 | K200493 | 000 |
| 37613327466127 | K200493 | 000 |
| 37613327466103 | K200493 | 000 |
| 37613327466097 | K200493 | 000 |
| 37613327466080 | K200493 | 000 |
| 37613327466073 | K200493 | 000 |
| 37613327466066 | K200493 | 000 |
| 37613327466059 | K200493 | 000 |
| 37613327466042 | K200493 | 000 |
| 37613327466028 | K200493 | 000 |
| 37613327466011 | K200493 | 000 |
| 37613327465922 | K200493 | 000 |