510(k) K921646

NEXTEC FIBEROPTIC ILLUMINATOR 300 WATT XENON by Nextec Corp. — Product Code FST

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1992
Date Received
April 6, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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