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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 K163535
Device Name my Patch sl
Applicant
DMS-SERVICE LLC
11845 W OLYMPIC BLVD
STE 880W
LOS ANGELES,  CA  90064
Applicant Contact LYNDA COLE
Correspondent
DMS-SERVICE LLC
11845 W OLYMPIC BLVD
STE 880W
LOS ANGELES,  CA  90064
Correspondent Contact LYNDA COLE
Regulation Number870.2800
Classification Product Code
DSH  
Date Received12/16/2016
Decision Date 02/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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