FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PELICAN BAY KEL-COR CEPHALOMETRIC SYS.
K Number: K791916
·
Decision Nov 5, 1979
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
20
Applicant Total
1
Review Days
41
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Basic Information
- Device Name
- PELICAN BAY KEL-COR CEPHALOMETRIC SYS.
- K Number
- K791916
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1880
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Pelican Bay Kel-Cor
- Date Received
- September 25, 1979
- Decision Date
- November 5, 1979
- Product Code
- IXY
- 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 |
|---|---|---|---|
| IXY | Holder, Radiographic Cassette, Wall-Mounted | FDA class 1 | Radiology |
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