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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 K941112
Device Name SINGLE HANDED BREAST PUMP
Applicant
MACNEIL BABY CARE LTD.
5161 THATCHER RD.
DOWNERS GROVE,  IL  60515
Applicant Contact BETH IVERSON
Correspondent
MACNEIL BABY CARE LTD.
5161 THATCHER RD.
DOWNERS GROVE,  IL  60515
Correspondent Contact BETH IVERSON
Regulation Number884.5160
Classification Product Code
HGX  
Date Received03/07/1994
Decision Date 01/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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