FDA 510(k) Application Details - K993833

Device Classification Name Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

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510(K) Number K993833
Device Name Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Applicant ALLEGIANCE HEALTHCARE CORP.
1500 WAUKEGAN RD.- K
MCGRAW PARK, IL 60085 US
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Contact SHARON ROBBINS
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Regulation Number 868.5270

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Classification Product Code BZE
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Date Received 11/12/1999
Decision Date 12/10/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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