510(k) K070376

CONMED LINVATEC 300W XENON LIGHT SOURCE by Conmed Linvatec — Product Code GCT

K070376 is an FDA 510(k) premarket notification submitted by Conmed Linvatec for the device "CONMED LINVATEC 300W XENON LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent on August 20, 2007. The device falls under product code GCT (Light Source, Endoscope, Xenon Arc), a Class II device regulated under 21 CFR 876.1500. Conmed Linvatec has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2007
Date Received
February 8, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Source, Endoscope, Xenon Arc
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type