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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 -7372
Applicant Contact dennis w henkelman
Correspondent
SIEMENS GAMMASONICS, INC.
2501 n. barrington rd.
hoffman estates,  IL  60195 -7372
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
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