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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 K081388
Device Name GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM
Applicant
PRONIA MEDICAL SYSTEM, LLC
49 PLAIN STREET
NORTH ATTLEBORO,  MA  02760
Applicant Contact CYNTHIA J.M. NOLTE
Correspondent
PRONIA MEDICAL SYSTEM, LLC
49 PLAIN STREET
NORTH ATTLEBORO,  MA  02760
Correspondent Contact CYNTHIA J.M. NOLTE
Regulation Number868.1890
Classification Product Code
NDC  
Date Received05/19/2008
Decision Date 08/21/2008
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
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