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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 K221924
Device Name Digital Routines
Applicant
Gnc Holdings, LLC
75 Hopper Pl
Pittsburgh,  PA  15222
Applicant Contact YongKai Wong
Correspondent
Gnc Holdings, LLC
75 Hopper Pl
Pittsburgh,  PA  15222
Correspondent Contact YongKai Wong
Regulation Number868.1890
Classification Product Code
NDC  
Date Received07/01/2022
Decision Date 03/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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