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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 K101344
Device Name G+ SYSTEM
Applicant
Glytec, LLC (Formally Known AS Glucotec, Inc.)
2607 Woodruff Rd.
Simpsonville,  SC  29681
Applicant Contact WILLIAM MATTHEWS
Correspondent
Glytec, LLC (Formally Known AS Glucotec, Inc.)
2607 Woodruff Rd.
Simpsonville,  SC  29681
Correspondent Contact WILLIAM MATTHEWS
Regulation Number868.1890
Classification Product Code
NDC  
Date Received05/13/2010
Decision Date 06/28/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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