510(k) K060802

VISUM LED SURGICAL LIGHTING SYSTEM by Stryker Communications Corp. — Product Code FSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2006
Date Received
March 24, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Light, Surgical, Ceiling Mounted
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type