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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Catheter, G-U
510(k) Number K120160
Device Name ROCAMED ROCAUS PLATINUM
Applicant
Promepla Sam
Le Copori-9 Ave.
Prince Albert Ii
Monaco,  MC MC 9800
Applicant Contact KRISTA JOHNSON
Correspondent
Promepla Sam
Le Copori-9 Ave.
Prince Albert Ii
Monaco,  MC MC 9800
Correspondent Contact KRISTA JOHNSON
Regulation Number876.5130
Classification Product Code
KNY  
Subsequent Product Code
KOD  
Date Received01/19/2012
Decision Date 05/14/2012
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
Predetermined Change
Control Plan Authorized		 No
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