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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Breast, Powered
510(k) Number K112856
Device Name LUCINA-MELODI
Applicant
GENADYNE BIOTECHNOLOGIES, INC.
16 MIDLAND AVE
HICKSVILLE,  NY  11801
Applicant Contact CHIEN-MING GOH
Correspondent
GENADYNE BIOTECHNOLOGIES, INC.
16 MIDLAND AVE
HICKSVILLE,  NY  11801
Correspondent Contact CHIEN-MING GOH
Regulation Number884.5160
Classification Product Code
HGX  
Date Received09/30/2011
Decision Date 05/10/2012
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 No
Predetermined Change
Control Plan Authorized		 No
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