510(k) K842997

LASER RECTOSCOPE SET 784 by Laser Industries , Ltd. — Product Code FDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1984
Date Received
July 30, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resectoscope, Working Element
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type