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FDA 510(k) Application Details - K960518
Device Classification Name
Ventilator, Non-Continuous (Respirator)
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
868.5905
More FDA Info for this Regulation Number
Classification Product Code
BZD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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