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510(k) K221836

Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus by Drägerwerk AG & Co KGaA — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2022
Date Received
June 23, 2022
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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