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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K874363
Device Name ACUSON S228 AND S328 TRANSDUCERS FOR ABDOM. APPLI.
Applicant
Acuson Computed Sonography
1220 Charleston Rd.
P.O. Box 7393
Mountain View,  CA  94039
Applicant Contact J GALLAGHER
Correspondent
Acuson Computed Sonography
1220 Charleston Rd.
P.O. Box 7393
Mountain View,  CA  94039
Correspondent Contact J GALLAGHER
Regulation Number892.1560
Classification Product Code
IYO  
Date Received10/23/1987
Decision Date 05/02/1988
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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