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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 K143574
Device Name Melodi Prime Breast Pump
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 Received12/17/2014
Decision Date 04/21/2015
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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