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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 K102516
Device Name LUCINA MODEL MELODI
Applicant
Genadyne Biotechnologies, Inc.
65 Watermill Lane
Great Neck,  NY  11021
Applicant Contact CHIEN MING(ANDREW)GOH
Correspondent
Genadyne Biotechnologies, Inc.
65 Watermill Lane
Great Neck,  NY  11021
Correspondent Contact CHIEN MING(ANDREW)GOH
Regulation Number884.5160
Classification Product Code
HGX  
Date Received09/02/2010
Decision Date 08/11/2011
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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