FDA 510(k) Application Details - K012958

Device Classification Name Filter, Bacterial, Breathing-Circuit

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510(K) Number K012958
Device Name Filter, Bacterial, Breathing-Circuit
Applicant EMERGENCY FILTRATION PRODUCTS, INC.
4335 SOUTH INDUSTRIAL RD.,#440
LAS VEGAS, NV 89103 US
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Contact DOUGLAS K BEPLATE
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Regulation Number 868.5260

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Classification Product Code CAH
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Date Received 09/04/2001
Decision Date 02/22/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K012958


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