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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K192413
Device Name SiteSeal Femoral Compression Device
Applicant
Ensite Vacular, LLC
10900 S. Clay Blair Blvd., Suite 800
Olathe,  KS  66061
Applicant Contact Tom Reidy
Correspondent
TAMM Net, Inc.
1 Clearwater Court
Damascus,  MD  20872
Correspondent Contact Shree Koushik
Regulation Number870.4450
Classification Product Code
DXC  
Date Received09/04/2019
Decision Date 03/31/2020
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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