FDA 510(k) Application Details - K001545

Device Classification Name Curette, Suction, Endometrial (And Accessories)

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510(K) Number K001545
Device Name Curette, Suction, Endometrial (And Accessories)
Applicant MILEX PRODUCTS, INC.
4311 NORTH NORMANDY AVE.
CHICAGO, IL 60634 US
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Contact CARA FURLONG
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Regulation Number 884.1175

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Classification Product Code HHK
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Date Received 05/18/2000
Decision Date 06/15/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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