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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 K032135
Device Name SITE-RITE IV ULTRASOUND SYSTEM
Applicant
Dymax Corp
271 Kappa Dr.
Pittsburgh,  PA  15238
Applicant Contact CHARLES MORREALE
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462 -1298
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received07/11/2003
Decision Date 07/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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