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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dilator, vessel, surgical
510(k) Number K030788
Device Name KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS
Applicant
GEISTER MEDIZINTECHNIK GMBH
AMSTEL 320-I
AMSTERDAM,  NL 1017 AP
Applicant Contact DAGMAR MASER
Correspondent
GEISTER MEDIZINTECHNIK GMBH
AMSTEL 320-I
AMSTERDAM,  NL 1017 AP
Correspondent Contact DAGMAR MASER
Regulation Number870.4475
Classification Product Code
DWP  
Date Received03/12/2003
Decision Date 07/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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