FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DYNAMIC EXTENSOR SPLINT
K Number: K800143
·
Decision Feb 19, 1980
Classifications
1
FEI Numbers
416
Registration Numbers
416
Same Product Code
35
Applicant Total
441
Review Days
29
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Basic Information
- Device Name
- DYNAMIC EXTENSOR SPLINT
- K Number
- K800143
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3475
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Biomet, Inc.
- Date Received
- January 21, 1980
- Decision Date
- February 19, 1980
- 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 |
Similar 510(k) Clearances
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UNIVERSAL WRIST SPLINT & FOREARM SPLINT
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WRIST SUPPORT
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