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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 K973501
Device Name EXPRESSE AND PREMIER POWERED BREAST PUMPS
Applicant
Ameda Medizintechnik AG
2000 Hollister Dr.
Libertyville,  IL  60048
Applicant Contact JOSEPH S TOKARZ
Correspondent
Ameda Medizintechnik AG
2000 Hollister Dr.
Libertyville,  IL  60048
Correspondent Contact JOSEPH S TOKARZ
Regulation Number884.5160
Classification Product Code
HGX  
Date Received09/16/1997
Decision Date 12/11/1997
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
Recalls CDRH Recalls
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