510(k) K860261

CANNULA BAND by T. G. & E. Medical — Product Code CAT

K860261 is an FDA 510(k) premarket notification submitted by T. G. & E. Medical for the device "CANNULA BAND". The FDA issued a decision of Substantially Equivalent on February 18, 1986. The device falls under product code CAT (Cannula, Nasal, Oxygen), a Class I device regulated under 21 CFR 868.5340. T. G. & E. Medical has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1986
Date Received
January 24, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Nasal, Oxygen
Device Class
Class I
Regulation Number
868.5340
Review Panel
AN
Submission Type