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
IXY Holder, Radiographic Cassette, Wall-Mounted

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