FDA 510(k) Application Details - K002506

Device Classification Name Filter, Bacterial, Breathing-Circuit

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510(K) Number K002506
Device Name Filter, Bacterial, Breathing-Circuit
Applicant SIMS PORTEX, INC.
10 BOWMAN DR.
KEENE, NH 03431 US
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Contact TIMOTHY J TALCOTT
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Regulation Number 868.5260

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Classification Product Code CAH
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Date Received 08/15/2000
Decision Date 12/14/2000
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



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