FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGEON'S CHOICE CRUTCH HANDLE
K Number: K831889
·
Decision Jul 7, 1983
Classifications
1
FEI Numbers
157
Registration Numbers
157
Same Product Code
7
Applicant Total
1
Review Days
23
Basic Information
- Device Name
- SURGEON'S CHOICE CRUTCH HANDLE
- K Number
- K831889
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3790
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- W.K. WHEELER, INC.
- Date Received
- June 14, 1983
- Decision Date
- July 7, 1983
- Product Code
- INP
- 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 |
|---|---|---|---|
| INP | Tips And Pads, Cane, Crutch And Walker | FDA class 1 | Physical Medicine |
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