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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 K223258
Device Name TNI Clear-Guard™ 3 angled breathing filter (1545020)
Applicant
Intersurgical Ltd.
Crane House
Molly Millars Lane, Wokingham
Berkshire,  GB RG41 2RZ
Applicant Contact Ivan Seniut
Correspondent
Intersurgical Incorporated
6757 Kinne Street
East Syracuse,  NY  13057
Correspondent Contact Kerrie Campbell
Regulation Number868.5260
Classification Product Code
CAH  
Date Received10/21/2022
Decision Date 06/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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