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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transport Systems, Anaerobic
510(k) Number K882637
Device Name ACCU-CULSHURE TM
Applicant
Accu-Med Corp.
270 Marble Ave.
Pleasantville,  NY  10570
Applicant Contact JOANN HANCHROW
Correspondent
Accu-Med Corp.
270 Marble Ave.
Pleasantville,  NY  10570
Correspondent Contact JOANN HANCHROW
Regulation Number866.2900
Classification Product Code
JTX  
Date Received06/27/1988
Decision Date 07/06/1988
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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