FDA 510(k) Application Details - K892520

Device Classification Name Filter, Bacterial, Breathing-Circuit

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510(K) Number K892520
Device Name Filter, Bacterial, Breathing-Circuit
Applicant ARBO MEDICAL, INC.
3728 PLAZA DR.
ANN ARBOR, MI US
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Contact DAWN I MOORE
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Regulation Number 868.5260

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Classification Product Code CAH
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Date Received 04/11/1989
Decision Date 08/02/1989
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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