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510(k) K132729

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2014
Date Received
September 3, 2013
Clearance Type
Special
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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