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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Drug Dose
510(k) Number K854249
Device Name COMPUTER ASSISTED DIABETIC INTRUCTION
Applicant
Applied Biomedical Computations, Inc.
815 Connecticut Ave.
Washington,  DC  20006
Applicant Contact JONATHAN S KAHAN
Correspondent
Applied Biomedical Computations, Inc.
815 Connecticut Ave.
Washington,  DC  20006
Correspondent Contact JONATHAN S KAHAN
Regulation Number868.1890
Classification Product Code
NDC  
Date Received10/22/1985
Decision Date 03/27/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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