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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pessary, Vaginal
510(k) Number K904774
Device Name INGLAT-O-BALL
Applicant
MILEX PRODUCTS, INC.
5915 NORTHWEST HIGHWAY
CHICAGO,  IL  60631
Applicant Contact GARY CHUVEN
Correspondent
MILEX PRODUCTS, INC.
5915 NORTHWEST HIGHWAY
CHICAGO,  IL  60631
Correspondent Contact GARY CHUVEN
Regulation Number884.3575
Classification Product Code
HHW  
Date Received10/22/1990
Decision Date 12/07/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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