510(k) K810059

ENDO-MED TUBE FOR ENDOTRACHEAL MED by Ackrad Laboratories — Product Code CCT

K810059 is an FDA 510(k) premarket notification submitted by Ackrad Laboratories for the device "ENDO-MED TUBE FOR ENDOTRACHEAL MED". The FDA issued a decision of Substantially Equivalent on February 26, 1981. The device falls under product code CCT (Applicator (Laryngo-Tracheal), Topical Anesthesia), a Class II device regulated under 21 CFR 868.5170. Ackrad Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1981
Date Received
January 13, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applicator (Laryngo-Tracheal), Topical Anesthesia
Device Class
Class II
Regulation Number
868.5170
Review Panel
AN
Submission Type