510(k) K875104

SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE by Laserguide — Product Code LLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1988
Date Received
December 18, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Neodymium:Yag, Pulmonary Surgery
Device Class
Class II
Regulation Number
874.4500
Review Panel
AN
Submission Type