510(k) K892432

KENDALL CURITY ENDOTRACHEAL TUBES by The Kendal Co. — Product Code BTR

K892432 is an FDA 510(k) premarket notification submitted by The Kendal Co. for the device "KENDALL CURITY ENDOTRACHEAL TUBES". The FDA issued a decision of Substantially Equivalent on June 12, 1989. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. The Kendal Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1989
Date Received
April 10, 1989
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