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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 K946283
Device Name COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUM
Applicant
Copan Diagnostics, Inc.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact MARY M MCNAMARA
Correspondent
Copan Diagnostics, Inc.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact MARY M MCNAMARA
Regulation Number866.2390
Classification Product Code
JSM  
Date Received12/27/1994
Decision Date 03/10/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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