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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reservoir, Blood, Cardiopulmonary Bypass
510(k) Number K083131
Device Name MEDOS HILITE RESERVOIR, MODEL: 4030
Applicant
Gish Biomedical, Inc.
22942 Arroyo Vista
Rancho Santa Margarita,  CA  92688
Applicant Contact JANET PEETS
Correspondent
Gish Biomedical, Inc.
22942 Arroyo Vista
Rancho Santa Margarita,  CA  92688
Correspondent Contact JANET PEETS
Regulation Number870.4400
Classification Product Code
DTN  
Date Received10/23/2008
Decision Date 07/30/2009
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
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