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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 K190022
Device Name SafeBreath Filter Mouthpiece
Applicant
MD Diagnostics Limited
15 Hollingworth Ct., Turkey Mill
Maidstone,  GB ME14 5PP
Applicant Contact Glen Hillsley
Correspondent
MD Diagnostics Limited
15 Hollingworth Ct., Turkey Mill
Maidstone,  GB ME14 5PP
Correspondent Contact Glen Hillsley
Regulation Number868.5260
Classification Product Code
CAH  
Date Received01/04/2019
Decision Date 09/25/2019
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
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