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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 K921261
Device Name ELECTRIC POWERED BREAST PUMP
Applicant
SCHUCO, INC.
1419 EXPRESSWAY DRIVE NORTH
TOLEDO,  OH  43608
Applicant Contact RALPH SPANG
Correspondent
SCHUCO, INC.
1419 EXPRESSWAY DRIVE NORTH
TOLEDO,  OH  43608
Correspondent Contact RALPH SPANG
Regulation Number884.5160
Classification Product Code
HGX  
Date Received03/16/1992
Decision Date 11/09/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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