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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 K001021
Device Name LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902
Applicant
DIDECO S.P.A.
195 WEST ST.
WALTHAM,  MA  02451 -1163
Applicant Contact BARRY SALL
Correspondent
DIDECO S.P.A.
195 WEST ST.
WALTHAM,  MA  02451 -1163
Correspondent Contact BARRY SALL
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received03/30/2000
Decision Date 04/25/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
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