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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Balloon Inflation
510(k) Number K042449
Device Name DOLPHIN INFLATION DEVICE
Applicant
Sedat S.A.
45900 Parsippany Court
Temecula,  CA  92592
Applicant Contact LAETITIA BERNARD
Correspondent
Sedat S.A.
45900 Parsippany Court
Temecula,  CA  92592
Correspondent Contact LAETITIA BERNARD
Regulation Number870.1650
Classification Product Code
MAV  
Date Received09/09/2004
Decision Date 04/18/2005
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
Recalls CDRH Recalls
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