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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous, neurovasculature
510(k) Number K200910
Device Name BOSS Balloon Guide Catheter
Applicant
Marblehead Medical
11600 96th Ave N
Maple Grove,  MN  55369
Applicant Contact Kristin Mortenson
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQY  
Date Received04/06/2020
Decision Date 05/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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