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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Non-Propagating Transport
510(k) Number K242976
Device Name Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device
Applicant
Medical Wire & Equipment Company (Bath), Ltd.
Unit 29 Potley Ln.
Corsham,  GB SN13 9RT
Applicant Contact Shedden Douglas
Correspondent
Medical Wire & Equipment Company (Bath), Ltd.
Unit 29 Potley Ln.
Corsham,  GB SN13 9RT
Correspondent Contact Shedden Douglas
Regulation Number866.2390
Classification Product Code
JSM  
Date Received09/26/2024
Decision Date 11/26/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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