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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 K231579
Device Name MOLLI 2
Applicant
Molli Surgical, Inc.
50 Wellington St. E.
Suite 400
Toronto,  CA M5E 1C8
Applicant Contact Joseph De Croos
Correspondent
Molli Surgical, Inc.
50 Wellington St. E.
Suite 400
Toronto,  CA M5E 1C8
Correspondent Contact Joseph De Croos
Regulation Number878.4300
Classification Product Code
NEU  
Date Received05/31/2023
Decision Date 10/26/2023
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
Predetermined Change
Control Plan Authorized		 No
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