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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K160704
Device Name myPatch-s
Applicant
Dms-Service, LLC
11845 W Olympic Blvd.
Suite 880w
Los Angeles,  CA  90064
Applicant Contact LYNDA COLE
Correspondent
Dms-Service, LLC
11845 W Olympic Blvd.
Suite 880w
Los Angeles,  CA  90064
Correspondent Contact LYNDA COLE
Regulation Number870.2800
Classification Product Code
DSH  
Date Received03/14/2016
Decision Date 07/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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