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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 K831929
Device Name BASIC BREAST PUMP
Applicant
TERAYCO INTL., LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
TERAYCO INTL., LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.5150
Classification Product Code
HGY  
Date Received06/15/1983
Decision Date 09/29/1983
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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