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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Magnetic Compression Anastomosis System
510(k) Number K242086
Device Name MagDI System (MAG-01, DS-01)
Applicant
Gt Metabolic Solutions, Inc.
3050 Three Springs Court
San Jose,  CA  95140
Applicant Contact Lisa Griffin Vincent
Correspondent
Gt Metabolic Solutions, Inc.
5450 Quam Ave. NE
Suite 100
St. Michael,  MN  55376
Correspondent Contact Lisa Griffin Vincent
Classification Product Code
SAH  
Subsequent Product Code
GAD  
Date Received07/17/2024
Decision Date 10/24/2024
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
Predetermined Change
Control Plan Authorized		 No
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