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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K190976
Device Name Radial Medical Compression System
Applicant
Radial Medical, Inc.
2500 Grant Rd.
Mountain View,  CA  94040
Applicant Contact Eric Johnson
Correspondent
Mark Smutka
10984 Northseal Square
Cupertina,  CA  95014
Correspondent Contact Mark Smutka
Regulation Number870.5800
Classification Product Code
JOW  
Date Received04/15/2019
Decision Date 07/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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