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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K180677
Device Name Surefire Spark Infusion System
Applicant
Surefire Medical, Inc.
6272 W. 91st Ave.
Westminster,  CO  80031
Applicant Contact Lynne Aronson
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.1200
Classification Product Code
DQO  
Date Received03/15/2018
Decision Date 04/03/2018
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
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