510(k) K924128

CHOLANGIOGRAPHY CATHETER by Applied Medical Resources — Product Code GBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1993
Date Received
August 17, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cholangiography
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type