FDA 510(k) Application Details - K080366

Device Classification Name Blood Pressure Cuff

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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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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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