STRYKER STRI-SHIELD FLYTE TOGAS
FDA 510(k) clearance K073017 · decided 2007-11-30
Clearance details
- K-number
- K073017
- Device name
- STRYKER STRI-SHIELD FLYTE TOGAS
- Applicant
- Stryker Instruments, Instruments Div.
- Decision
- Substantially Equivalent
- Date received
- 2007-10-25
- Decision date
- 2007-11-30
- Days to decision
- 36 days
- Clearance type
- Special
- Product code
- FYA
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Kalamazoo, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Flyte Togas are components of the Stryker Flyte System and are intended to be worn over an recall (Z-1077-2015) | Stryker Instruments Div. of Stryker Corporation | 2015-02-10 |