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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 K103028
Device Name EEVATM PETRI DISH
Applicant
Auxogyn, Inc.
1490 O'Brien Dr.
Suite A
Menlo Park,  CA  94545
Applicant Contact ROBERT NEWMAN
Correspondent
Auxogyn, Inc.
1490 O'Brien Dr.
Suite A
Menlo Park,  CA  94545
Correspondent Contact ROBERT NEWMAN
Regulation Number884.6160
Classification Product Code
MQK  
Date Received10/13/2010
Decision Date 08/11/2011
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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