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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, Specialized Obstetric-Gynecologic
510(k) Number K861385
Device Name MILEX BARTHOLIN GLAND CATHETER
Applicant
MILEX PRODUCTS, INC.
5915 NORTHWEST HIGHWAY
CHICAGO,  IL  60631
Applicant Contact ROBERT SHAW
Correspondent
MILEX PRODUCTS, INC.
5915 NORTHWEST HIGHWAY
CHICAGO,  IL  60631
Correspondent Contact ROBERT SHAW
Regulation Number884.4530
Classification Product Code
KNA  
Date Received04/14/1986
Decision Date 06/16/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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