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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antimicrobial Blood Pressure Cuff
510(k) Number K122365
Device Name ULTRACHECK CURVE BLOOD PRESSURE CUFFS
Applicant
Statcorp Medical
14476 Duval Pl W Suite 303
Jacksonville,  FL  32218
Applicant Contact WAYNE EMMERT
Correspondent
Statcorp Medical
14476 Duval Pl W Suite 303
Jacksonville,  FL  32218
Correspondent Contact WAYNE EMMERT
Regulation Number870.1120
Classification Product Code
OED  
Date Received08/06/2012
Decision Date 06/04/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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