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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 K190152
Device Name Vit Kit- Freeze NX and Vit Kit- Warm NX
Applicant
Fujifilm Irvine Scientific, Inc.
2511 Daimler St.
Santa Ana,  CA  92705
Applicant Contact Jayme Yamaguchi-Owens
Correspondent
Fujifilm Irine Scientific, Inc.
2511 Daimler St.
Santa Ana,  CA  92705
Correspondent Contact Jayme Yamaguchi-Owens
Regulation Number884.6180
Classification Product Code
MQL  
Date Received01/30/2019
Decision Date 06/21/2019
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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