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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Labware, Assisted Reproduction
510(k) Number K123641
Device Name CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH
Applicant
Hertart
Korskildelund 6
Greve,  DK 2670
Applicant Contact HENRIK DORGE
Correspondent
Hertart
Korskildelund 6
Greve,  DK 2670
Correspondent Contact HENRIK DORGE
Regulation Number884.6160
Classification Product Code
MQK  
Date Received11/26/2012
Decision Date 07/03/2013
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
Predetermined Change
Control Plan Authorized		 No
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