510(k) K935157

ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBES by Regulatory Consultants TO the Medical Device Indus — Product Code KPX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1994
Date Received
October 28, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Changer, Radiographic Film/Cassette
Device Class
Class II
Regulation Number
892.1860
Review Panel
RA
Submission Type