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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Marker, Radiographic, Implantable
510(k) Number K231468
Device Name SCOUT MD Surgical Guidance System
Applicant
Merit Medical System, Inc.
1600 West Merit Parkway
South Jordan,  UT  84095
Applicant Contact Saboo Sandeep
Correspondent
Merit Medical System, Inc.
1600 West Merit Parkway
South Jordan,  UT  84095
Correspondent Contact Saboo Sandeep
Regulation Number878.4300
Classification Product Code
NEU  
Date Received05/22/2023
Decision Date 02/12/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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