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510(k) K160950

MINISCAV by Sedation Systems, LLC — Product Code CBN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2017
Date Received
April 5, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Gas-Scavenging
Device Class
Class II
Regulation Number
868.5430
Review Panel
AN
Submission Type

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