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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K133296
Device Name XCATH
Applicant
Alseal
1468 Harwell Ave.,
Crofton,  MD  21114
Applicant Contact YOLANDA SMITH
Correspondent
Alseal
1468 Harwell Ave.,
Crofton,  MD  21114
Correspondent Contact YOLANDA SMITH
Regulation Number870.1340
Classification Product Code
DYB  
Date Received10/25/2013
Decision Date 02/14/2014
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
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