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510(k) K190022

SafeBreath Filter Mouthpiece by MD Diagnostics Limited — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2019
Date Received
January 4, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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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