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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, Selective And Non-Differential
510(k) Number K852987
Device Name CARIESCREEN - SM
Applicant
Pharma-Medica of Scandinavia, Ltd.
91 Esna Park Dr., Unit 2
Markham(Toronto)
Ontario L3r 2s2 Canada,  CA
Applicant Contact MARMEL
Correspondent
Pharma-Medica of Scandinavia, Ltd.
91 Esna Park Dr., Unit 2
Markham(Toronto)
Ontario L3r 2s2 Canada,  CA
Correspondent Contact MARMEL
Regulation Number866.2360
Classification Product Code
JSJ  
Date Received07/15/1985
Decision Date 08/19/1985
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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