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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 K153461
Device Name Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm
Applicant
MAQUET CRITICAL CARE AB
RONTGENVAGEN 2
SOLNA,  SE SE-171 54
Applicant Contact Mirva Boothe
Correspondent
MAQUET MEDICAL SYSTEMS USA
45 BARBOUR POND DRIVE
WAYNE,  NJ  07470
Correspondent Contact Linda Slutzky
Regulation Number876.5980
Classification Product Code
KNT  
Date Received12/01/2015
Decision Date 12/11/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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