510(k) K843544

THE BIBICURE SYS BREAST TONER by Les Entreprises Bibi, Inc. — Product Code HGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1985
Date Received
September 7, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Breast, Non-Powered
Device Class
Class I
Regulation Number
884.5150
Review Panel
OB
Submission Type