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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 K051926
Device Name LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP
Applicant
Limerick, Inc.
1313-23rd Rd.
Kanopolis,  KS  67454
Applicant Contact PAUL KRUMM
Correspondent
Limerick, Inc.
1313-23rd Rd.
Kanopolis,  KS  67454
Correspondent Contact PAUL KRUMM
Regulation Number884.5160
Classification Product Code
HGX  
Date Received07/18/2005
Decision Date 12/12/2005
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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