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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Curette, Suction, Endometrial (And Accessories)
510(k) Number K001545
Device Name PIPET CURET
Applicant
MILEX PRODUCTS, INC.
4311 NORTH NORMANDY AVE.
CHICAGO,  IL  60634
Applicant Contact CARA FURLONG
Correspondent
MILEX PRODUCTS, INC.
4311 NORTH NORMANDY AVE.
CHICAGO,  IL  60634
Correspondent Contact CARA FURLONG
Regulation Number884.1175
Classification Product Code
HHK  
Date Received05/18/2000
Decision Date 06/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Special
Reviewed by Third Party No
Combination Product No
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