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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 K884674
Device Name APEX 415 ANGER CAMERA
Applicant
Elscint, Inc.
930 Commonwealth Ave.
Boston,  MA  02215
Applicant Contact SOBEL
Correspondent
Elscint, Inc.
930 Commonwealth Ave.
Boston,  MA  02215
Correspondent Contact SOBEL
Regulation Number892.1100
Classification Product Code
IYX  
Date Received11/08/1988
Decision Date 04/17/1989
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
Recalls CDRH Recalls
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