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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 K903469
Device Name GAMMA 600 NUCLEAR MEDICINE COMPUTER
Applicant
STRICHMAN MEDICAL EQUIPMENT, INC.
93 WEST TECH CENTER
MEDFIELD,  MA  02052
Applicant Contact MARK DOHERTY
Correspondent
STRICHMAN MEDICAL EQUIPMENT, INC.
93 WEST TECH CENTER
MEDFIELD,  MA  02052
Correspondent Contact MARK DOHERTY
Regulation Number892.1100
Classification Product Code
IYX  
Date Received08/01/1990
Decision Date 02/04/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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