510(k) K864166

25 WATT CARBON DIOXIDE MEDICAL LASER FOR NEUROLOGY by Weck Surgical Systems — Product Code LKW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1987
Date Received
October 23, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Neurosurgical
Device Class
Class III
Regulation Number
Review Panel
NE
Submission Type