510(k) K934531

AUTO SUTURE DISPOSABLE LIGHT CABLE by United States Surgical, A Division of Tyco Healthc — Product Code FCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1994
Date Received
September 20, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Source, Fiberoptic, Routine
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type