FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RADIAL TRAVEL SPEC. PROCEDURES TABLE
K Number: K761339
·
Decision Jan 5, 1977
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
28
Applicant Total
20
Review Days
9
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Basic Information
- Device Name
- RADIAL TRAVEL SPEC. PROCEDURES TABLE
- K Number
- K761339
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1980
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Xre Corp.
- Date Received
- December 27, 1976
- Decision Date
- January 5, 1977
- Product Code
- IZZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IZZ | Table, Radiographic, Non-Tilting, Powered | FDA class 2 | Radiology |
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| K913685 | UNICATH EP. | Nov 7, 1991 | Substantially Equivalent |
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