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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 K212287
Device Name Dayspring Lite
Applicant
Koya Medical, Inc.
2461 Peralta St.
Oakland,  CA  94607
Applicant Contact Jarren Baldwin
Correspondent
Biodesign Regulatory Services, LLC
16185 Los Gatos Blvd.
Los Gatos,  CA  95032
Correspondent Contact Alex Chang
Regulation Number870.5800
Classification Product Code
JOW  
Date Received07/21/2021
Decision Date 09/21/2021
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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