510(k) K950930

TRACHE-TITE by The Varner Group, Inc. — Product Code CBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1995
Date Received
March 1, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Fixation, Tracheal Tube
Device Class
Class I
Regulation Number
868.5770
Review Panel
AN
Submission Type