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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 K030850
Device Name ENHANCE HUMAN SERUM ALBUMIN
Applicant
Conception Technologies
3722 Ave. Sausalito
Irvine,  CA  92606
Applicant Contact GRACE HOLLAND
Correspondent
Conception Technologies
3722 Ave. Sausalito
Irvine,  CA  92606
Correspondent Contact GRACE HOLLAND
Regulation Number884.6180
Classification Product Code
MQL  
Date Received03/17/2003
Decision Date 04/08/2003
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 No
Predetermined Change
Control Plan Authorized		 No
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