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510(k) K050918

KOO AMERICAS VALVE PEEP, MODEL KM-809 by Koo Americas, Inc. — Product Code BYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2005
Date Received
April 12, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Attachment, Breathing, Positive End Expiratory Pressure
Device Class
Class II
Regulation Number
868.5965
Review Panel
AN
Submission Type

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