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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 K082472
Device Name VIROCULT, MODEL MW950
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  
Date Received08/28/2008
Decision Date 12/30/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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