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510(k) K013884

BOUSSIGNAC C.P.A.P. DEVICE by Vygon SA — Product Code BYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2003
Date Received
November 23, 2001
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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