510(k) K962828

EVERT-IT by Genesis Industries, Inc. — Product Code HGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1997
Date Received
July 19, 1996
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