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FDA 510(k) Application Details - K960995
Device Classification Name
Valve, Non-Rebreathing
More FDA Info for this Device
510(K) Number
K960995
Device Name
Valve, Non-Rebreathing
Applicant
O-TWO SYSTEMS INTL., INC.
7575 KIMBEL ST., UNIT 5
MISSISSAUGA
ONTARIO L5S 1C8 CA
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Contact
KEVIN BOWDEN
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Regulation Number
868.5870
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Classification Product Code
CBP
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More FDA Info for this Product Code
Date Received
03/12/1996
Decision Date
01/07/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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