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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digitizer, Image, Radiological
510(k) Number K032022
Device Name DIGITAL IMAGER
Applicant
PYRAMID MEDICAL, INC.
10940 PORTAL MEDICAL DR.
LOS ALAMITOS,  CA  90720
Applicant Contact CLAUDE BENNETT
Correspondent
PYRAMID MEDICAL, INC.
10940 PORTAL MEDICAL DR.
LOS ALAMITOS,  CA  90720
Correspondent Contact CLAUDE BENNETT
Regulation Number892.2030
Classification Product Code
LMA  
Date Received06/30/2003
Decision Date 09/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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