510(k) K953368

LUER, JACKSON TRACHEA TUBES, LUER SPEAKING TRACHEA TUBES by Karl Storz Endoskop GmbH — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1995
Date Received
July 18, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5730
Review Panel
AN
Submission Type