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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, non-powered
510(k) Number K844297
Device Name SUPPLEMENTAL FEEDING SYSTEM
Applicant
MEDELA, INC.
6711 SANDS RD.
CRYSTAL LAKE,  IL  60014
Applicant Contact GOTTHILF WEINIGER
Correspondent
MEDELA, INC.
6711 SANDS RD.
CRYSTAL LAKE,  IL  60014
Correspondent Contact GOTTHILF WEINIGER
Regulation Number884.5150
Classification Product Code
HGY  
Date Received10/29/1984
Decision Date 02/25/1985
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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