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510(k) K210992

Altech® Exhalation Valve (Single Limb and Dual Limb) by Meditera Tibbi Malzeme San VE Tic AS — Product Code CBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2021
Date Received
April 2, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valve, Non-Rebreathing
Device Class
Class II
Regulation Number
868.5870
Review Panel
AN
Submission Type

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