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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 ste 303
jacksonville,  FL  32218
Applicant Contact wayne emmert
Correspondent
STATCORP MEDICAL
14476 duval pl w ste 303
jacksonville,  FL  32218
Correspodent 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
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