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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
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
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