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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 K113853
Device Name G+ SYSTEM
Applicant
GLYTEC, LLC
665 N. ACADEMY ST.
GREENVILLE,  SC  29601
Applicant Contact WILLIAM MATTHEWS
Correspondent
GLYTEC, LLC
665 N. ACADEMY ST.
GREENVILLE,  SC  29601
Correspondent Contact WILLIAM MATTHEWS
Regulation Number868.1890
Classification Product Code
NDC  
Date Received12/29/2011
Decision Date 05/08/2012
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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