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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 K892888
Device Name EXTACISER PERINEAL MUSCLE EXERCISER
Applicant
Bivona Medical Technologies
5700 W. 23rd Ave.
Gary,  IN  46406
Applicant Contact SHAPIRO, M.D.
Correspondent
Bivona Medical Technologies
5700 W. 23rd Ave.
Gary,  IN  46406
Correspondent Contact SHAPIRO, M.D.
Regulation Number884.1425
Classification Product Code
HIR  
Date Received04/20/1989
Decision Date 10/05/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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