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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Scanning, Nuclear
510(k) Number K915541
Device Name SPECT TABLE, MODEL #056-760
Applicant
Atomic Products Corp.
P.O. Drawer R
Shirley,  NY  11967
Applicant Contact CLYDE SCHLEIN
Correspondent
Atomic Products Corp.
P.O. Drawer R
Shirley,  NY  11967
Correspondent Contact CLYDE SCHLEIN
Regulation Number892.1350
Classification Product Code
IYZ  
Date Received12/10/1991
Decision Date 01/17/1992
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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