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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 K925626
Device Name MAXIMA PLUS HOLLOW FIBER OXYGENATOR
Applicant
MEDTRONIC VASCULAR
4633 E. LA PALMA AVE.
ANAHEIM,  CA  92807
Applicant Contact NORMA L LOWE
Correspondent
MEDTRONIC VASCULAR
4633 E. LA PALMA AVE.
ANAHEIM,  CA  92807
Correspondent Contact NORMA L LOWE
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received11/06/1992
Decision Date 02/05/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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