FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CROWNTEX EXAM. CAPE & GOWN
K Number: K760954
·
Decision Dec 30, 1976
Classifications
1
FEI Numbers
234
Registration Numbers
234
Same Product Code
4
Applicant Total
1
Review Days
58
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Basic Information
- Device Name
- CROWNTEX EXAM. CAPE & GOWN
- K Number
- K760954
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6265
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Graham Manufacturing Co.
- Date Received
- November 2, 1976
- Decision Date
- December 30, 1976
- Product Code
- FME
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| FME | Gown, Examination | FDA class 1 | General Hospital |
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