FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRACTION WEIGHT BAGS
K Number: K780233
·
Decision Feb 23, 1978
Classifications
1
FEI Numbers
205
Registration Numbers
205
Same Product Code
37
Applicant Total
441
Review Days
14
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Basic Information
- Device Name
- TRACTION WEIGHT BAGS
- K Number
- K780233
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.5850
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Biomet, Inc.
- Date Received
- February 9, 1978
- Decision Date
- February 23, 1978
- Product Code
- HST
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HST | Apparatus, Traction, Non-Powered | FDA class 1 | Orthopedic |
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