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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 K221836
Device Name Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus
Applicant
Drägerwerk AG & Co, Kgaa
Moislinger Allee 53-55
Schleswig-Holstein
Luebeck,  DE 23542
Applicant Contact Luise Lang
Correspondent
Drägerwerk AG & Co, Kgaa
Moislinger Allee 53-55
Schleswig-Holstein
Luebeck,  DE 23542
Correspondent Contact Luise Lang
Regulation Number868.5260
Classification Product Code
CAH  
Date Received06/23/2022
Decision Date 12/07/2022
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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