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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Coupling, Ultrasound
510(k) Number K102637
Device Name DYNAREX ULTRASOUND GEL
Applicant
Dynarex Corporation
10 Glenshaw St.
Orangeburg,  NY  10962
Applicant Contact DANIEL CONSAGA
Correspondent
Dynarex Corporation
10 Glenshaw St.
Orangeburg,  NY  10962
Correspondent Contact DANIEL CONSAGA
Regulation Number892.1570
Classification Product Code
MUI  
Date Received09/14/2010
Decision Date 02/16/2011
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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