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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, For Percutaneous Catheterization
510(k) Number K913027
Device Name VESSEL DILATOR
Applicant
Deseret Medical, Inc.
9450 S St.ate St.
Sandy,  UT  84070
Applicant Contact BECTON DICKINSON
Correspondent
Deseret Medical, Inc.
9450 S St.ate St.
Sandy,  UT  84070
Correspondent Contact BECTON DICKINSON
Regulation Number870.1310
Classification Product Code
DRE  
Date Received07/09/1991
Decision Date 11/27/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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