FDA 510(k) Application Details - K980662

Device Classification Name Filter, Bacterial, Breathing-Circuit

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510(K) Number K980662
Device Name Filter, Bacterial, Breathing-Circuit
Applicant DHD HEALTHCARE CORP.
ONE MADISON ST.
WAMPSVILLE, NY 13163 US
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Contact JEAN WALLACE
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Regulation Number 868.5260

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Classification Product Code CAH
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Date Received 02/20/1998
Decision Date 09/14/1998
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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