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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 K200564
Device Name Aria System
Applicant
Inova Labs
7581 Convoy Court
san diego,  CA  92111
Applicant Contact reuben lawson
Correspondent
Accelerated Device Approval Services, LLC
6800 S.W. 40th Street, Ste. 403
ludlum,  FL  33155
Correspondent Contact rafael aguila
Regulation Number870.5800
Classification Product Code
JOW  
Date Received03/04/2020
Decision Date 04/03/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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