510(k) K896667

LORENZ STENT by Walter Lorenz Surgical, Inc. — Product Code FWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1990
Date Received
November 27, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Larynx (Stents And Keels)
Device Class
Class II
Regulation Number
874.3620
Review Panel
EN
Submission Type