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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 K132500
Device Name CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED
Applicant
CURE MEDICAL LLC.
257 GARNET GARDEN STREET
HENDERSON,  NV  89015
Applicant Contact JOHN BEASLEY
Correspondent
CURE MEDICAL LLC.
257 GARNET GARDEN STREET
HENDERSON,  NV  89015
Correspondent Contact JOHN BEASLEY
Regulation Number876.5130
Classification Product Code
EZD  
Date Received08/09/2013
Decision Date 12/23/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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