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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 K951247
Device Name SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS
Applicant
BAXTER HEALTHCARE CORP.
17511 ARMSTRONG AVE.
P.O.BOX 19522
IRVINE,  CA  92713 -9522
Applicant Contact SCOTT BEGGINS
Correspondent
BAXTER HEALTHCARE CORP.
17511 ARMSTRONG AVE.
P.O.BOX 19522
IRVINE,  CA  92713 -9522
Correspondent Contact SCOTT BEGGINS
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received03/20/1995
Decision Date 11/02/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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