FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MURPHY ADJUSTABLE SPLINT
K Number: K854270
·
Decision Dec 9, 1985
Classifications
1
FEI Numbers
115
Registration Numbers
115
Same Product Code
10
Applicant Total
4
Review Days
47
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Basic Information
- Device Name
- MURPHY ADJUSTABLE SPLINT
- K Number
- K854270
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.5890
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Comfortex, Inc.
- Date Received
- October 23, 1985
- Decision Date
- December 9, 1985
- Product Code
- KQZ
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| KQZ | Component, Traction, Non-Invasive | FDA class 1 | Orthopedic |
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