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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 K760911
Device Name BREAST CARE KIT
Applicant
AMERICAN HOSPITAL SUPPLY CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AMERICAN HOSPITAL SUPPLY CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.5150
Classification Product Code
HGY  
Date Received10/27/1976
Decision Date 11/11/1976
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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