510(k) K823461

AXIPUMP MANUAL BREAST PUMP by D.J. Colgate Medical, Ltd. — Product Code HGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1983
Date Received
November 19, 1982
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