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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 K903767
Device Name ECT (EMMISSION COMPUTED TOMOGRAPHY) CARBON FIB PAL
Applicant
Siemens Gammasonics, Inc.
2501 N. Barrington Rd.
Hoffman Estates,  IL  60195
Applicant Contact DENNIS W HENKELMAN
Correspondent
Siemens Gammasonics, Inc.
2501 N. Barrington Rd.
Hoffman Estates,  IL  60195
Correspondent Contact DENNIS W HENKELMAN
Regulation Number892.1350
Classification Product Code
IYZ  
Date Received08/20/1990
Decision Date 09/07/1990
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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