FDA 510(k) Application Details - K023356

Device Classification Name Blood Pressure Cuff

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510(K) Number K023356
Device Name Blood Pressure Cuff
Applicant CARD GUARD SCIENTIFIC SURVIVAL, LTD.
2 PEKERIS ST.
REHOVOT 76100 IL
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Contact ALEX GONOROVSKY
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 10/07/2002
Decision Date 01/16/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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