FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACE WIRE TENSION CLAMP
K Number: K894982
·
Decision Jan 11, 1990
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
84
Applicant Total
111
Review Days
156
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Basic Information
- Device Name
- ACE WIRE TENSION CLAMP
- K Number
- K894982
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Buckman Co., Inc.
- Date Received
- August 8, 1989
- Decision Date
- January 11, 1990
- Product Code
- JEC
- 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 |
|---|---|---|---|
| JEC | Component, Traction, Invasive | FDA class 2 | Orthopedic |
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