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510(k) K123176

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2013
Date Received
October 10, 2012
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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