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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope Holder
510(k) Number K102179
Device Name ENVIEW (TM)
Applicant
Carefusion 2200
6215 Ferris Sq.,
Suite #100
San Diego,  CA  92121
Applicant Contact PATRICIA A AYERS
Correspondent
Carefusion 2200
6215 Ferris Sq.,
Suite #100
San Diego,  CA  92121
Correspondent Contact PATRICIA A AYERS
Regulation Number876.1500
Classification Product Code
OCV  
Date Received08/03/2010
Decision Date 12/02/2010
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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