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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 K113737
Device Name SUREFIRE GUIDE SHEATH
Applicant
SUREFIRE MEDICAL, INC
12415 sw 136 avenue
unit 3
miami,  FL  33186
Applicant Contact mario arbesu
Correspondent
SUREFIRE MEDICAL, INC
12415 sw 136 avenue
unit 3
miami,  FL  33186
Correspondent Contact mario arbesu
Regulation Number870.1200
Classification Product Code
DQO  
Date Received12/20/2011
Decision Date 02/23/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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