Home / 510(k) Clearances / K202459

510(k) K202459

Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter by Pharma System AB — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2021
Date Received
August 27, 2020
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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