FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FOAM COMFORT RINGS
K Number: K781246
·
Decision Aug 10, 1978
Classifications
1
FEI Numbers
374
Registration Numbers
374
Same Product Code
22
Applicant Total
5
Review Days
20
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Basic Information
- Device Name
- FOAM COMFORT RINGS
- K Number
- K781246
- 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
- July 21, 1978
- Decision Date
- August 10, 1978
- 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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