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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 K163023
Device Name Other-Sonic Transmission Gel
Applicant
Pharmaceutical Innovations, Inc.
897 Frelinghuysen Ave.
Newark,  NJ  07114
Applicant Contact SHIRLEY J. BERGMAN
Correspondent
Pharmaceutical Innovations, Inc.
897 Frelinghuysen Ave.
Newark,  NJ  07114
Correspondent Contact SHIRLEY J. BERGMAN
Regulation Number892.1570
Classification Product Code
MUI  
Date Received10/31/2016
Decision Date 01/08/2018
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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