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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 Doppler, Ultrasonic
510(k) Number K926351
Device Name COLORMARK(TM) VISUALIZATION SYSTEM
Applicant
Echocath, Inc.
P.O. Box 7224
Princeton,  NJ  08543
Applicant Contact FRANK DEBERNARDIS
Correspondent
Echocath, Inc.
P.O. Box 7224
Princeton,  NJ  08543
Correspondent Contact FRANK DEBERNARDIS
Regulation Number892.1550
Classification Product Code
IYN  
Date Received12/17/1992
Decision Date 09/16/1993
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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