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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, percutaneous retrieval
510(k) Number K200963
Device Name Halo Single-Loop Microsnare Kit
Applicant
Argon Medical Devices, Inc.
1445 Flat Creek Road
Athens,  TX  75751
Applicant Contact Ana Jimenez-Hughes
Correspondent
Argon Medical Devices, Inc.
1445 Flat Creek Road
Athens,  TX  75751
Correspondent Contact Ana Jimenez-Hughes
Regulation Number870.5150
Classification Product Code
MMX  
Subsequent Product Code
DQY  
Date Received04/10/2020
Decision Date 01/05/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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