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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K980600
Device Name D903 AVANT ADULT HOLLOW FIBER OXYGENATOR
Applicant
Dideco S.P.A.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact MARCO MANTOVANI
Correspondent
Dideco S.P.A.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact MARCO MANTOVANI
Regulation Number870.5800
Classification Product Code
JOW  
Date Received02/17/1998
Decision Date 08/12/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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