FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPLINT WOOD
K Number: K832144
·
Decision Aug 1, 1983
Classifications
1
FEI Numbers
416
Registration Numbers
416
Same Product Code
35
Applicant Total
1
Review Days
32
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Basic Information
- Device Name
- SPLINT WOOD
- K Number
- K832144
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3475
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Vermont Wood Industries, Inc.
- Date Received
- June 30, 1983
- Decision Date
- August 1, 1983
- Product Code
- ILH
- 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 |
|---|---|---|---|
| ILH | Splint, Hand, And Components | FDA class 1 | Physical Medicine |
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