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FDA 510(k) Application Details - K122365
Device Classification Name
Antimicrobial Blood Pressure Cuff
More FDA Info for this Device
510(K) Number
K122365
Device Name
Antimicrobial Blood Pressure Cuff
Applicant
STATCORP MEDICAL
14476 Duval Pl W Ste 303
JACKSONVILLE, FL 32218 US
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Contact
WAYNE EMMERT
Other 510(k) Applications for this Contact
Regulation Number
870.1120
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Classification Product Code
OED
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More FDA Info for this Product Code
Date Received
08/06/2012
Decision Date
06/04/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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