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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rectal Insert
510(k) Number K243367
Device Name Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)
Applicant
Minnesota Medical Technologies
2446 Henry Rd. NW
Stewartville,  MN  55976
Applicant Contact Robert Anglin
Correspondent
Sachs & Associates, Inc.
16 Crescent Ln.
North Oaks,  MN  55127
Correspondent Contact Gregory Sachs
Regulation Number876.5980
Classification Product Code
PBP  
Date Received10/30/2024
Decision Date 07/22/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT03934463
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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