FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COMFOR FOAM LIMB HOLDERS- SINGLE STRAP
K Number: K963462
·
Decision Nov 21, 1996
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
133
Applicant Total
1
Review Days
79
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Basic Information
- Device Name
- COMFOR FOAM LIMB HOLDERS- SINGLE STRAP
- K Number
- K963462
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6760
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bird & Cronin, Inc.
- Date Received
- September 3, 1996
- Decision Date
- November 21, 1996
- Product Code
- FMQ
- 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 |
|---|---|---|---|
| FMQ | Restraint, Protective | FDA class 1 | General Hospital |
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