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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Scintillation (Gamma)
510(k) Number K900773
Device Name NUCLEAR MAX
Applicant
Scientific Imaging, Inc.
6032 S.Brook Valley Way
Littleton,  CO  80121
Applicant Contact LEAR, M.D.
Correspondent
Scientific Imaging, Inc.
6032 S.Brook Valley Way
Littleton,  CO  80121
Correspondent Contact LEAR, M.D.
Regulation Number892.1100
Classification Product Code
IYX  
Date Received02/16/1990
Decision Date 05/23/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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