510(k) K881499

SURGILASE YAG 100 FOR GYNECOLOGY USE by Surgilase, Inc. — Product Code LLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1988
Date Received
March 22, 1988
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