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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Tubes With Enteral Specific Connectors
510(k) Number K153688
Device Name Edi Catheter ENFit
Applicant
Maquet Critical Care AB
Rontgenvagen 2
Solna,  SE SE-171 54
Applicant Contact MIRVA BOOTHE
Correspondent
Maquet Medical System USA
45 Barbour Pond Dr.
Wayne,  NJ  07470
Correspondent Contact Mark Dinger
Regulation Number876.5980
Classification Product Code
PIF  
Subsequent Product Code
CBK  
Date Received12/23/2015
Decision Date 03/02/2017
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
Recalls CDRH Recalls
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