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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dilator, cervical, synthetic, osmotic
510(k) Number K143447
Device Name Dilapan-S
Applicant
Medicem Technology s.r.o.
Karlovarska Trida 20
Kamenne Zehrovice,  CZ 273 01
Applicant Contact Adam Vlcek
Correspondent
Susanne Parks
206 Ellington Road
Graham,  NC  27253
Correspondent Contact Susanne Parks
Regulation Number884.4260
Classification Product Code
PKN  
Date Received12/02/2014
Decision Date 04/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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