510(k) K893866

HOOD PEDIATRIC TRACHEOSTOMY TUBE by Hood Laboratories — Product Code BTO

K893866 is an FDA 510(k) premarket notification submitted by Hood Laboratories for the device "HOOD PEDIATRIC TRACHEOSTOMY TUBE". The FDA issued a decision of Substantially Equivalent on August 7, 1989. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. Hood Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1989
Date Received
May 26, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheostomy (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5800
Review Panel
AN
Submission Type