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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K240884
Device Name Glide (91000-GL-X)
Applicant
Infinite Biomedical Technologies, LLC
8 Market Pl.
Suite 500
Baltimore,  MD  21202
Applicant Contact Damini Agarwal
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number882.1320
Classification Product Code
GXY  
Subsequent Product Code
IQZ  
Date Received04/01/2024
Decision Date 04/15/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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