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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 K162689
Device Name Vibrance Pelvic Trainer
Applicant
Bioinfinity (M) Sdn. Bhd.
# 21, Jalan 4/62 A, Bandar Menjalara, Kepong
Kepong,  MY 52200
Applicant Contact NG SHEA KANG
Correspondent
Emergo Group
2500 Bee Cave Rd.
Bldg. 1, Suite 300
Austin,  TX  78746
Correspondent Contact CARRIE HETRICK
Regulation Number884.1425
Classification Product Code
HIR  
Date Received09/27/2016
Decision Date 06/08/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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