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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
510(k) Number K162359
Device Name Surefire Guiding Catheter
Applicant
Surefire Medical, Inc.
6272 W. 91st Avenue
Westminster,  CO  80031
Applicant Contact Lynne Aronson
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/23/2016
Decision Date 09/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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