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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 K070047
Device Name NUNC IVF DISHES AND NUNC IVF 4-WELL DISH
Applicant
Nunc A/S
Kamstrupuej 90, Kamstrup
Roskilde,  DK DK-4000
Applicant Contact JANA S HELLMANN
Correspondent
Nunc A/S
Kamstrupuej 90, Kamstrup
Roskilde,  DK DK-4000
Correspondent Contact JANA S HELLMANN
Regulation Number884.6160
Classification Product Code
MQK  
Date Received01/04/2007
Decision Date 05/18/2007
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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