510(k) K954619

CORDGUARD II by Utah Medical Products, Inc. — Product Code KNA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1995
Date Received
October 5, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, Specialized Obstetric-Gynecologic
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type