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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 K082512
Device Name INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER
Applicant
Dimensional Dosing Systems, Inc.
1468 Harwell Ave.
Crofton,  MD  21114
Applicant Contact EJ Smith
Correspondent
Dimensional Dosing Systems, Inc.
1468 Harwell Ave.
Crofton,  MD  21114
Correspondent Contact EJ Smith
Regulation Number868.1890
Classification Product Code
NDC  
Date Received08/29/2008
Decision Date 11/07/2008
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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