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510(k) K192713

Altera Filter and HME/Filter by Meditera Tibbi Malzeme San VE Tic AS — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2020
Date Received
September 27, 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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