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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 K971543
Device Name LUXMATIC 12-15 ISC PORTABLE ELECTRIC BREAST PUMP
Applicant
KAWECO GMBH
55 NORTHERN BLVD., SUITE 410
GREAT NECK,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
KAWECO GMBH
55 NORTHERN BLVD., SUITE 410
GREAT NECK,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number884.5160
Classification Product Code
HGX  
Date Received04/28/1997
Decision Date 09/18/1997
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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