510(k) K872031

UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM by Laser Media — Product Code LNK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1987
Date Received
May 26, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser For Gastro-Urology Use
Device Class
Class II
Regulation Number
878.4810
Review Panel
GU
Submission Type