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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 K121128
Device Name MULTIPURPOSE HANDLING MEDIUM
Applicant
Irvine Scientific Sales Co., Inc.
2511 Daimler St.
Santa Ana,  CA  92705
Applicant Contact JAYME YAMAGUCHI-OWENS
Correspondent
Irvine Scientific Sales Co., Inc.
2511 Daimler St.
Santa Ana,  CA  92705
Correspondent Contact JAYME YAMAGUCHI-OWENS
Regulation Number884.6180
Classification Product Code
MQL  
Date Received04/13/2012
Decision Date 06/06/2012
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 Yes
Predetermined Change
Control Plan Authorized		 No
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