510(k) K955687

RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAY by Contour Fabricators of Florida, Inc. — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1996
Date Received
December 14, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type