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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 K072539
Device Name CURE CATHETER
Applicant
Cure Medical, LLC
28241 Crown Valley Pkwy.
Suite 510
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
EZD  
Subsequent Product Code
GBM  
Date Received09/10/2007
Decision Date 09/13/2007
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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