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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oxygenator, Cardiopulmonary Bypass
510(k) Number K090450
Device Name MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT
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 Number870.4350
Classification Product Code
DTZ  
Date Received02/20/2009
Decision Date 09/18/2009
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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