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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 K151070
Device Name Sonishield 100 Antimicrobial Ultrasound Gel
Quotient Medical
3365 Harvester Road, Suite 110
Burlington,  CA L7N 3N2
Applicant Contact David Okamoto
Lockhart Regulatory Services Inc.
1860 Appleby Line, Suite 348
Burlington,  CA L7L 7H7
Correspondent Contact Marilyn Lockhart
Regulation Number892.1570
Classification Product Code
Date Received04/21/2015
Decision Date 01/13/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No