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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K101199
Device Name GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER,
Applicant
MAQUET CRITICAL CARE AB
45 BORBOUR POND DRIVE
WAYNE,  NJ  07470
Applicant Contact WHITNEY TORNING
Correspondent
MAQUET CRITICAL CARE AB
45 BORBOUR POND DRIVE
WAYNE,  NJ  07470
Correspondent Contact WHITNEY TORNING
Regulation Number876.5980
Classification Product Code
KNT  
Date Received04/29/2010
Decision Date 08/27/2010
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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