FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LIGHT WEIGHT ALUMINUM CRUTCHES
K Number: K821403
·
Decision Jun 21, 1982
Classifications
1
FEI Numbers
196
Registration Numbers
196
Same Product Code
3
Applicant Total
4
Review Days
41
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Basic Information
- Device Name
- LIGHT WEIGHT ALUMINUM CRUTCHES
- K Number
- K821403
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3150
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Manuco Manufacturing Co., Inc.
- Date Received
- May 11, 1982
- Decision Date
- June 21, 1982
- Product Code
- IPR
- 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 |
|---|---|---|---|
| IPR | Crutch | FDA class 1 | Physical Medicine |
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