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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 K014080
Device Name APEX ADULT HOLLOWE FIBER OXYGENATOR
Applicant
DIDECO S.P.A.
195 WEST ST.
WALTHAM,  MA  02451 -1163
Applicant Contact BARRY S SALL
Correspondent
DIDECO S.P.A.
195 WEST ST.
WALTHAM,  MA  02451 -1163
Correspondent Contact BARRY S SALL
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received12/11/2001
Decision Date 01/08/2002
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
Recalls CDRH Recalls
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