510(k) K974563

COLPO CUP CVC-2000 by Clinical Innovations, Inc. — Product Code HDP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1998
Date Received
December 5, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Elevator, Uterine
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type