FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEEL/ELBOW PROTECTORS
K Number: K791709
·
Decision Sep 24, 1979
Classifications
1
FEI Numbers
374
Registration Numbers
374
Same Product Code
22
Applicant Total
5
Review Days
28
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Basic Information
- Device Name
- HEEL/ELBOW PROTECTORS
- K Number
- K791709
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6450
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Fibre Formations, Inc.
- Date Received
- August 27, 1979
- Decision Date
- September 24, 1979
- Product Code
- FMP
- 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 |
|---|---|---|---|
| FMP | Protector, Skin Pressure | FDA class 1 | General Hospital |
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