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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 K122800
Device Name INNER PEACE
Applicant
Kamabry, Inc., Dba Inner Peace For Women
1468 Harwell Have
Crofton,  MD  21114
Applicant Contact YOLANDA SMITH
Correspondent
Kamabry, Inc., Dba Inner Peace For Women
1468 Harwell Have
Crofton,  MD  21114
Correspondent Contact YOLANDA SMITH
Regulation Number884.1425
Classification Product Code
HIR  
Date Received09/12/2012
Decision Date 10/04/2013
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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