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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Assisted Reproduction
510(k) Number K092183
Device Name EMBRYOSCOPE AND EMBRYOSLIDE
Applicant
Unisense Fertilitech A/S
Brendstrupgardsvej 21f
Arrhus,  DK DK-8200
Applicant Contact METTE MUNCH
Correspondent
Unisense Fertilitech A/S
Brendstrupgardsvej 21f
Arrhus,  DK DK-8200
Correspondent Contact METTE MUNCH
Regulation Number884.6120
Classification Product Code
MQG  
Subsequent Product Codes
MQK   MTX  
Date Received07/21/2009
Decision Date 01/11/2011
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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