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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Blood, Cardiopulmonary Bypass, Arterial Line
510(k) Number K031323
Device Name DBT, DYNAMIC BUBBLE TRAP
Applicant
Convergenza AG
3625 Woodlake Dr.
Bonita Springs,  FL  34134
Applicant Contact CHRISTIE DEWITT
Correspondent
Convergenza AG
3625 Woodlake Dr.
Bonita Springs,  FL  34134
Correspondent Contact CHRISTIE DEWITT
Regulation Number870.4260
Classification Product Code
DTM  
Date Received04/25/2003
Decision Date 08/01/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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