FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FEMORAL CEMENT REMOVAL INSTRUMENT
K Number: K840735
·
Decision May 14, 1984
Classifications
1
FEI Numbers
304
Registration Numbers
304
Same Product Code
1
Applicant Total
1
Review Days
83
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Basic Information
- Device Name
- FEMORAL CEMENT REMOVAL INSTRUMENT
- K Number
- K840735
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Amtech Scientific, Inc.
- Date Received
- February 21, 1984
- Decision Date
- May 14, 1984
- Product Code
- HWX
- 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 |
|---|---|---|---|
| HWX | Tap, Bone | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HWX), ordered by most recent decision date.
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