510(k) K921918

FIBER OPTIC ENDOSCOPE by Electro Fiberoptics Corp. — Product Code GCM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1993
Date Received
April 23, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Rigid
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type