510(k) K840943

ENDO-JECT by Autovage — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 1984
Date Received
March 5, 1984
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