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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 K254102
Device Name Glucommander
Applicant
Glytec, LLC
200 N Main St.
Greenville,  SC  29601
Applicant Contact Robby Booth
Correspondent
Glytec, LLC
200 N Main St.
Greenville,  SC  29601
Correspondent Contact Robby Booth
Regulation Number868.1890
Classification Product Code
NDC  
Date Received12/19/2025
Decision Date 05/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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