FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HOOD, OPERATING, SURGICAL
K Number: K904969
·
Decision Dec 12, 1990
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
12
Applicant Total
1
Review Days
37
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Basic Information
- Device Name
- HOOD, OPERATING, SURGICAL
- K Number
- K904969
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Chicago Assoc. For Retarded Citizens
- Date Received
- November 5, 1990
- Decision Date
- December 12, 1990
- 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 |
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