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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 K023305
Device Name KEGELMASTER 2000
Applicant
Kegelmaster 2000 , Ltd.
P.O. Box 4341
Crofton,  MD  21114
Applicant Contact YOLANDA SMITH
Correspondent
Kegelmaster 2000 , Ltd.
P.O. Box 4341
Crofton,  MD  21114
Correspondent Contact YOLANDA SMITH
Regulation Number884.1425
Classification Product Code
HIR  
Date Received10/03/2002
Decision Date 12/26/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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