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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 K030264
Device Name QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030
Applicant
Jostra AG
Hechinger Strasse 38
Hirrlingen,  DE 72145
Applicant Contact KATRIN SCHWENKGLENKS
Correspondent
Jostra AG
Hechinger Strasse 38
Hirrlingen,  DE 72145
Correspondent Contact KATRIN SCHWENKGLENKS
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received01/27/2003
Decision Date 02/26/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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