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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Lesion, Radiofrequency
510(k) Number K203293
Device Name Abbott Medical Grounding Pad, model RF-DGP-IS
Applicant
ABBOTT MEDICAL
5050 Nathan Ln.
Plymouth,  MN  55442
Applicant Contact Jordan Hanson
Correspondent
ABBOTT MEDICAL
5050 Nathan Ln.
Plymouth,  MN  55442
Correspondent Contact Jordan Hanson
Regulation Number882.4400
Classification Product Code
GXD  
Date Received11/09/2020
Decision Date 01/21/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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