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FDA 510(k) Application Details - K152801
Device Classification Name
Blood Pressure Cuff
More FDA Info for this Device
510(K) Number
K152801
Device Name
Blood Pressure Cuff
Applicant
STATCORP MEDICAL
14476 Duval Place West
Suite 303
JACKSONVILLE, FL 32218 US
Other 510(k) Applications for this Company
Contact
WAYNE EMMERT
Other 510(k) Applications for this Contact
Regulation Number
870.1120
More FDA Info for this Regulation Number
Classification Product Code
DXQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/28/2015
Decision Date
10/27/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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