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510(k) K143700

CPAP Cannulaide by Salter Labs — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2015
Date Received
December 24, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Non-Continuous (Respirator)
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

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