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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 K141663
Device Name EEVA DISH (WITH 12 MICROWELLS)
Applicant
AUXOGYN, INC.
1490 O'BRIEN DRIVE, SUITE A
MENLO PARK,  CA  94025
Applicant Contact JULIA S ANASTAS
Correspondent
AUXOGYN, INC.
1490 O'BRIEN DRIVE, SUITE A
MENLO PARK,  CA  94025
Correspondent Contact JULIA S ANASTAS
Regulation Number884.6160
Classification Product Code
MQK  
Date Received06/23/2014
Decision Date 07/22/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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