FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CAST BRACE COMPONENTS
K Number: K791057
·
Decision Jun 20, 1979
Classifications
1
FEI Numbers
503
Registration Numbers
503
Same Product Code
51
Applicant Total
331
Review Days
12
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Basic Information
- Device Name
- CAST BRACE COMPONENTS
- K Number
- K791057
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3475
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- 3M Company
- Date Received
- June 8, 1979
- Decision Date
- June 20, 1979
- Product Code
- IQI
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IQI | Orthosis, Limb Brace | FDA class 1 | Physical Medicine |
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