FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DR7700 OPERATING TABLE
K Number: K864325
·
Decision Nov 19, 1986
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
34
Applicant Total
5
Review Days
16
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Basic Information
- Device Name
- DR7700 OPERATING TABLE
- K Number
- K864325
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4960
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Koken Mfg Company, Inc.
- Date Received
- November 3, 1986
- Decision Date
- November 19, 1986
- Product Code
- FQO
- 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 |
|---|---|---|---|
| FQO | Table, Operating-Room, Ac-Powered | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Koken Mfg Company, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K864501 | KOKEN'S NEW MODEL M-3000 POWER TABLE | Dec 16, 1986 | Substantially Equivalent |
| K864574 | MAC 150E OPTHALMIC CHAIR | Dec 15, 1986 | Substantially Equivalent |
| K864494 | MODEL 6500 OPTHALMIC CHAIR | Dec 15, 1986 | Substantially Equivalent |
| K864295 | DR.500O OPERATING TABLE | Nov 19, 1986 | Substantially Equivalent |