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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 K193288
Device Name Koya Ripple
Applicant
Koya, Inc.
357 Tehama Street Ste. 1
San Francisco,  CA  94103
Applicant Contact Andy Doraiswamy
Correspondent
Medical Device Academy, Inc.
345 Lincoln Hill Road
Shrewsbury,  VT  05738
Correspondent Contact Robert V. Packard
Regulation Number870.5800
Classification Product Code
JOW  
Date Received11/27/2019
Decision Date 06/16/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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