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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 K843955
Device Name EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR
Applicant
Extracorporeal Medical Specialities, Inc.
P.O. Box 386
King Of Prussia,  PA  19406
Applicant Contact JAMES J BRENNAN
Correspondent
Extracorporeal Medical Specialities, Inc.
P.O. Box 386
King Of Prussia,  PA  19406
Correspondent Contact JAMES J BRENNAN
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received10/09/1984
Decision Date 11/29/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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