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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 K040717
Device Name NUNC IVF MULTIDISH 4 WELLS NUNCLON
Applicant
NUNC A/S
KAMSTRUPUEJ 90, KAMSTRUP
ROSKILDE,  DK DK-4000
Applicant Contact HENRIK KVISTGAARD
Correspondent
NUNC A/S
KAMSTRUPUEJ 90, KAMSTRUP
ROSKILDE,  DK DK-4000
Correspondent Contact HENRIK KVISTGAARD
Regulation Number884.6160
Classification Product Code
MQK  
Date Received03/19/2004
Decision Date 08/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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