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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 K964637
Device Name CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDIA
Applicant
Medical Packaging Corp.
941 Avenida Acaso
Camarillo,  CA  93012 -8700
Applicant Contact PATRICIA V WILLIS
Correspondent
Medical Packaging Corp.
941 Avenida Acaso
Camarillo,  CA  93012 -8700
Correspondent Contact PATRICIA V WILLIS
Regulation Number866.2390
Classification Product Code
JSM  
Date Received11/19/1996
Decision Date 12/24/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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