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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 K992559
Device Name HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010
Applicant
Jostra Bentley
2035 Sunset Lake Rd.
Newark,  DE  19702
Applicant Contact KATHY JOHNSON
Correspondent
Jostra Bentley
2035 Sunset Lake Rd.
Newark,  DE  19702
Correspondent Contact KATHY JOHNSON
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received07/30/1999
Decision Date 09/20/1999
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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