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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 K190628
Device Name FlexSeal Introducer Sheath with Hydrophilic Coating
Applicant
Freudenberg Medical Mis, Inc.
2301 Centennial Blvd.
Jeffersonville,  IN  47130
Applicant Contact Larry Bender
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Mark Job
Regulation Number870.1340
Classification Product Code
DYB  
Date Received03/12/2019
Decision Date 05/30/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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