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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, For Isolation Of Pathogenic Neisseria
510(k) Number K853237
Device Name APL MARTIN LEWIS MEDIUM
Applicant
Apl Medical Supplies
4230 S. Burnham Ave. #250
P.O. Box 14280
Las Vegas,  NV  89114
Applicant Contact JOHN WIECHEC
Correspondent
Apl Medical Supplies
4230 S. Burnham Ave. #250
P.O. Box 14280
Las Vegas,  NV  89114
Correspondent Contact JOHN WIECHEC
Regulation Number866.2410
Classification Product Code
JTY  
Date Received08/01/1985
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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