FDA 510(k)
FDA class 1
Substantially Equivalent
🇯🇵 Japan
TABLE, OPERATING ROOM, HYDRAULIC
K Number: K863161
·
Decision Sep 5, 1986
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
5
Applicant Total
4
Review Days
18
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Basic Information
- Device Name
- TABLE, OPERATING ROOM, HYDRAULIC
- K Number
- K863161
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4960
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Kamiya Tsusan Kaisha, Ltd.
- Date Received
- August 18, 1986
- Decision Date
- September 5, 1986
- Product Code
- FWW
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FWW | Table, Operating-Room, Pneumatic | FDA class 1 | General, Plastic Surgery |
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