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FDA 510(k) Application Details - K080366
Device Classification Name
Blood Pressure Cuff
More FDA Info for this Device
510(K) Number
K080366
Device Name
Blood Pressure Cuff
Applicant
ZEFON INTL.
5350 S.W. FIRST LN.
OCALA, FL 34474 US
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Contact
SCOTT RYAN
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Regulation Number
870.1120
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Classification Product Code
DXQ
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More FDA Info for this Product Code
Date Received
02/12/2008
Decision Date
06/09/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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