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510(k) K163300

ThermoShield HME Filter by Flexicare Medical Limited. — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2017
Date Received
November 22, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Filter, Bacterial, Breathing-Circuit
Device Class
Class II
Regulation Number
868.5260
Review Panel
HO
Submission Type

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