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FDA 510(k) Application Details - K151461
Device Classification Name
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
More FDA Info for this Device
510(K) Number
K151461
Device Name
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Applicant
PLASTIFLEX GROUP NV
BEVERLOOSESTEENWEG 99
PAAL-BERINGEN 3583 BE
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Contact
RAF VAN ROY
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Regulation Number
868.5270
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Classification Product Code
BZE
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More FDA Info for this Product Code
Date Received
06/01/2015
Decision Date
03/24/2016
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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