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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 K042620
Device Name SONATA 3-D IMAGING ACCESSORY, MODEL 3DS
Applicant
Tetrad Corp.
357 Inverness Dr. S.,
Suite A
Englewood,  CO  80112
Applicant Contact DENNIS R DIETZ
Correspondent
Tetrad Corp.
357 Inverness Dr. S.,
Suite A
Englewood,  CO  80112
Correspondent Contact DENNIS R DIETZ
Regulation Number892.1560
Classification Product Code
IYO  
Date Received09/27/2004
Decision Date 12/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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