FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OPERATING ROOM STAND
K Number: K840027
·
Decision Feb 4, 1984
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
12
Applicant Total
3
Review Days
30
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Basic Information
- Device Name
- OPERATING ROOM STAND
- K Number
- K840027
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4950
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Healthmate, Inc.
- Date Received
- January 5, 1984
- Decision Date
- February 4, 1984
- Product Code
- FSE
- 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 |
|---|---|---|---|
| FSE | Table, Operating-Room, Manual | FDA class 1 | General, Plastic Surgery |
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