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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Coupling, Ultrasound
510(k) Number K163050
Device Name Advance Medical Designs, Inc. Sterile Ultrasound Gel
Applicant
Advance Medical Designs, Inc.
1241 Atlanta Industrial Dr.
Marietta,  GA  30066
Applicant Contact DAVID MACKIE
Correspondent
Advance Medical Designs, Inc.
1241 Atlanta Industrial Dr.
Marietta,  GA  30066
Correspondent Contact DAVID MACKIE
Regulation Number892.1570
Classification Product Code
MUI  
Date Received11/01/2016
Decision Date 10/25/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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