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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wire, guide, catheter
510(k) Number K122506
Device Name SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS
Applicant
SUREFIRE MEDICAL, INC
12415 SW 136 AVENUE
UNIT 3
MIAMI,  FL  33186
Applicant Contact MARIO ARBESU
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.1330
Classification Product Code
DQX  
Date Received08/17/2012
Decision Date 09/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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