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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 K212655
Device Name Flyte
Applicant
Pelvital USA, Inc.
1000 Lasalle Ave., Sch 435
Minneapolis,  MN  55403
Applicant Contact Dale Wahlstrom
Correspondent
Winegar Consulting, Inc.
7829 Ithaca Ln N
Maple Grove,  MN  55311
Correspondent Contact Mike Winegar
Regulation Number884.1425
Classification Product Code
HIR  
Date Received08/23/2021
Decision Date 09/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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