FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover
K Number: K200493
·
Decision Mar 21, 2020
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
12
Applicant Total
81
Review Days
22
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Basic Information
- 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
- K Number
- K200493
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Stryker Corporation
- Date Received
- February 28, 2020
- Decision Date
- March 21, 2020
- Product Code
- FXY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FXY | Hood, Surgical | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FXY), ordered by most recent decision date.
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STERI-SHIELD
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