510(k) K910577

EDWARDS-WALLACE BOURNE HALL CATHETER by Marlo Surgical Technology — Product Code MFD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1991
Date Received
February 11, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Intrauterine Insemination
Device Class
Class II
Regulation Number
884.5250
Review Panel
OB
Submission Type