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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K080881
Device Name CURE CATHETER CLOSED SYSTEM
Applicant
CURE MEDICAL LLC.
29442 POINTE ROYAL
LAGUNA NIGUEL,  CA  92677
Applicant Contact James Smith
Correspondent
UNDERWRITERS LABORATORIES, INC.
1285 WALT WHITMAN RD.
MELVILLE,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number876.5130
Classification Product Code
KOD  
Subsequent Product Code
FCM  
Date Received03/31/2008
Decision Date 06/11/2008
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 Yes
Predetermined Change
Control Plan Authorized		 No
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