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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Specimen Collection
510(k) Number K103805
Device Name MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE
Applicant
Medical Wire & Equipment Company (Bath), Ltd.
Potley Ln.
Corsham, Wiltshire,  GB SN13 9RT
Applicant Contact DAVID ELLIS
Correspondent
Medical Wire & Equipment Company (Bath), Ltd.
Potley Ln.
Corsham, Wiltshire,  GB SN13 9RT
Correspondent Contact DAVID ELLIS
Regulation Number866.2900
Classification Product Code
LIO  
Subsequent Product Code
JTW  
Date Received12/28/2010
Decision Date 01/25/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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