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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 K083509
Device Name LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA
Applicant
GENX INTL., INC.
393 SOUNDVIEW RD.
GUILFORD,  CT  06437
Applicant Contact MICHAEL D CECCHI
Correspondent
GENX INTL., INC.
393 SOUNDVIEW RD.
GUILFORD,  CT  06437
Correspondent Contact MICHAEL D CECCHI
Regulation Number884.6180
Classification Product Code
MQL  
Date Received11/26/2008
Decision Date 04/24/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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