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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K210992
Device Name Altech® Exhalation Valve (Single Limb and Dual Limb)
Applicant
Meditera Tibbi Malzeme San Ve TIC AS
Ibni Melek OSB Mah, TOSHI Yol 4 Sol. No. 29 Tire
Organize sanayi Bolgesi
Tire Izmir,  TR 35900
Applicant Contact Cenk Kilic Kalkan
Correspondent
Meditera Tibbi Malzeme San Ve TIC AS c/o ProMedic LLC
131 Bay Point Dr NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.5870
Classification Product Code
CBP  
Date Received04/02/2021
Decision Date 12/23/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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