FDA 510(k) Application Details - K960518

Device Classification Name Ventilator, Non-Continuous (Respirator)

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510(K) Number K960518
Device Name Ventilator, Non-Continuous (Respirator)
Applicant PURITAN BENNETT CORP.
9728 PFLUMM RD.
P.O.BOX 15915
LENEXA, KS 66215-5915 US
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Contact C. MARSHALL SMITH
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Regulation Number 868.5905

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Classification Product Code BZD
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Date Received 02/05/1996
Decision Date 05/09/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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