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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Perineometer
510(k) Number K233362
Device Name Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)
Applicant
Pelvital USA, Inc.
860 Blue Gentian Rd. Suite 200
Eagan,  MN  55121
Applicant Contact Lydia Zeller
Correspondent
Pelvital USA, Inc.
860 Blue Gentian Rd. Suite 200
Eagan,  MN  55121
Correspondent Contact Pamela Snyder
Regulation Number884.1425
Classification Product Code
HIR  
Date Received10/02/2023
Decision Date 12/29/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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