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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scanner, Whole Body, Nuclear
510(k) Number K842895
Device Name WBA - I.R.I.S.
Applicant
Siemens Gammasonics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Siemens Gammasonics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.1330
Classification Product Code
JAM  
Date Received07/23/1984
Decision Date 08/27/1984
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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