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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name introducer, catheter
510(k) Number K233432
Device Name 10F Sheath and Dilator Set
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 Number870.1340
Classification Product Code
DYB  
Date Received10/12/2023
Decision Date 12/08/2023
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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