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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Reproductive
510(k) Number K170681
Device Name Continuous Single Culture -NX (CSCM-NX)
Applicant
Irvine Scientific Sales Co., Inc.
2511 Daimler Street
Santa Ana,  CA  92705
Applicant Contact Jayme Yamaguchi-Owens
Correspondent
Irvine Scientific Sales Co., Inc.
2511 Daimler Street
Santa Ana,  CA  92705
Correspondent Contact Jayme Yamaguchi-Owens
Regulation Number884.6180
Classification Product Code
MQL  
Date Received03/06/2017
Decision Date 06/08/2017
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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