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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reservoir, Blood, Cardiopulmonary Bypass
510(k) Number K001602
Device Name DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.)
Applicant
Dideco S.P.A.
195 W. St.
Waltham,  MA  02451
Applicant Contact BARRY SALL
Correspondent
Dideco S.P.A.
195 W. St.
Waltham,  MA  02451
Correspondent Contact BARRY SALL
Regulation Number870.4400
Classification Product Code
DTN  
Date Received05/24/2000
Decision Date 06/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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