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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 K132619
Device Name CLASSIC INTERMITTENT CATHETER
Applicant
FLEXICARE MEDICAL LTD.
CYNON VALLEY BUSINESS PARK
MOUTAIN ASH
MID GLAMORGAN,  GB CF45 4ER
Applicant Contact CHRISTOPHER WATKINS
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number876.5130
Classification Product Code
EZD  
Date Received08/21/2013
Decision Date 10/11/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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