Altera Filter And HME/Filter

Filter, Bacterial, Breathing-circuit

Meditera Tibbi Malzeme San. Ve Tic. A.S.

The following data is part of a premarket notification filed by Meditera Tibbi Malzeme San. Ve Tic. A.s. with the FDA for Altera Filter And Hme/filter.

Pre-market Notification Details

Device IDK192713
510k NumberK192713
Device Name:Altera Filter And HME/Filter
ClassificationFilter, Bacterial, Breathing-circuit
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
ContactCenk Kilic Kalkan
CorrespondentPaul Dryden
Meditera Tibbi Malzeme San. Ve Tic. A.S. % ProMedic, LLC 131 Bay Point Dr NE St. Petersburg,  FL  33704
Product CodeCAH  
CFR Regulation Number868.5260 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyAnesthesiology
510k Review PanelGeneral Hospital
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-27
Decision Date2020-03-16

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