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510(k) K003684

PERCUSSIVENEB, MODEL PN-2001 by Vortran Medical Technology 1, Inc. — Product Code NHJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2001
Date Received
November 29, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Positive Pressure Breathing, Intermittent
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

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