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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 K862410
Device Name MILEX KEGEL PERINEAL EXERCISER
Applicant
Milex Products, Inc.
5915 Northwest Hwy.
Chicago,  IL  60631
Applicant Contact ROBERT SHAW
Correspondent
Milex Products, Inc.
5915 Northwest Hwy.
Chicago,  IL  60631
Correspondent Contact ROBERT SHAW
Regulation Number884.1425
Classification Product Code
HIR  
Date Received06/25/1986
Decision Date 07/31/1986
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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