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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 K843544
Device Name THE BIBICURE SYS BREAST TONER
Applicant
LES ENTREPRISES BIBI, INC.
55 LOUVAIN AUEST SUITE 418
QUEBEC
MONTREAL H2N1A4,  CA
Applicant Contact PIA DAMTSIS
Correspondent
LES ENTREPRISES BIBI, INC.
55 LOUVAIN AUEST SUITE 418
QUEBEC
MONTREAL H2N1A4,  CA
Correspondent Contact PIA DAMTSIS
Regulation Number884.5150
Classification Product Code
HGY  
Date Received09/07/1984
Decision Date 01/25/1985
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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