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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 K153620
Device Name Enovare Ultrasound System
Applicant
Oreon Technologies, Inc.
520 White Plains Rd.
Harrytown,  NY  10591
Applicant Contact Howard Fidel
Correspondent
Oreon Technologies, Inc.
520 White Plains Rd.
Harrytown,  NY  10591
Correspondent Contact Howard Fidel
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
IYN   IYX  
Date Received12/18/2015
Decision Date 05/05/2016
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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