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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Flush
510(k) Number K082163
Device Name FLOWMEDICA BENEPHIT INFUSION SYSTEMS
Applicant
Flowmedica, Inc.
46563 Fremont Blvd.
Fremont,  CA  94538
Applicant Contact JEFF ELKINS
Correspondent
Flowmedica, Inc.
46563 Fremont Blvd.
Fremont,  CA  94538
Correspondent Contact JEFF ELKINS
Regulation Number870.1210
Classification Product Code
KRA  
Subsequent Product Code
DYB  
Date Received07/31/2008
Decision Date 10/29/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
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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