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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name filter, bacterial, breathing-circuit
510(k) Number K192713
Device Name Altera Filter and HME/Filter
Applicant
Meditera Tibbi Malzeme San. ve Tic. A.S.
Ibni Melek OSB Mah. TOSBI Yol 4 Sok
No: 29 Tire Organize Sanayi Bolgesi, Tire
Izmir,  TR 35900
Applicant Contact Cenk Kilic Kalkan
Correspondent
Meditera Tibbi Malzeme San. ve Tic. A.S. % ProMedic, LLC
131 Bay Point Dr NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.5260
Classification Product Code
CAH  
Date Received09/27/2019
Decision Date 03/16/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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