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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 K203847
Device Name Reprocessed Tri Pulse Compression Garment
Applicant
Renu Medical, Inc.
830 80th St. SW
Suite 100
Everett,  WA  98203
Applicant Contact Darren DeMerritt
Correspondent
Renu Medical, Inc.
830 80th St. SW
Suite 100
Everett,  WA  98203
Correspondent Contact Darren DeMerritt
Regulation Number870.5800
Classification Product Code
JOW  
Date Received12/31/2020
Decision Date 05/07/2021
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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