FDA 510(k) Application Details - K895233

Device Classification Name Filter, Bacterial, Breathing-Circuit

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510(K) Number K895233
Device Name Filter, Bacterial, Breathing-Circuit
Applicant F.L.W. PLASTICS, INC.
4920 N. WARREN DR.
COLUMBUS, IN US
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Contact D STRUTHERS
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Regulation Number 868.5260

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Classification Product Code CAH
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Date Received 08/21/1989
Decision Date 11/15/1989
Decision SE - Substantially Equivalent
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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