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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 K000737
Device Name COAXIAL DILATOR SET
Applicant
Xentek Medical, Inc.
6136 Fm1616
Athens,  TX  75751
Applicant Contact JIM EDDINGS
Correspondent
Xentek Medical, Inc.
6136 Fm1616
Athens,  TX  75751
Correspondent Contact JIM EDDINGS
Regulation Number870.1310
Classification Product Code
DRE  
Date Received03/07/2000
Decision Date 08/01/2000
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
Recalls CDRH Recalls
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