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510(k) K142138

ISO-GARD MASK by Teleflexmedical, Inc. — Product Code CBN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2014
Date Received
August 5, 2014
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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