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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 K971877
Device Name LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR
Applicant
Dideco S.P.A.
1601 Trapelo Rd.
Waltham,  MA  02154
Applicant Contact BARRY SALL
Correspondent
Dideco S.P.A.
1601 Trapelo Rd.
Waltham,  MA  02154
Correspondent Contact BARRY SALL
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received05/21/1997
Decision Date 10/08/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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