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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 K970597
Device Name CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM WITH CLINICAL TRANSPORT MEDIA (CARY-BLAIR OPTION)
Applicant
Medical Packaging Corp.
941 Avenida Acaso
Camarillo,  CA  93012
Applicant Contact PATRICIA V WILLIS
Correspondent
Medical Packaging Corp.
941 Avenida Acaso
Camarillo,  CA  93012
Correspondent Contact PATRICIA V WILLIS
Regulation Number866.2390
Classification Product Code
JSM  
Date Received02/18/1997
Decision Date 03/24/1997
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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