FDA 510(k) Application Details - K093126

Device Classification Name Dropper, Ether

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510(K) Number K093126
Device Name Dropper, Ether
Applicant HOSPITECH RESPIRATION LTD.
31 HAAVODA ST
BINYAMINA 30500 IL
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Contact YORAM LEVY
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Regulation Number 868.5420

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Classification Product Code BTP
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Date Received 10/02/2009
Decision Date 03/02/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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