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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 K932337
Device Name CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM
Applicant
Medical Packaging Corp.
3 Bethesda Metro Center
Suite 750
Bethesda,  MD  20814
Applicant Contact JOYCE T DAVIS
Correspondent
Medical Packaging Corp.
3 Bethesda Metro Center
Suite 750
Bethesda,  MD  20814
Correspondent Contact JOYCE T DAVIS
Regulation Number866.2390
Classification Product Code
JSM  
Date Received05/14/1993
Decision Date 08/16/1994
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
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