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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, straight
510(k) Number K103086
Device Name DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC
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 Number876.5130
Classification Product Code
EZD  
Date Received10/19/2010
Decision Date 06/07/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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