510(k) K902896

49-610 NIKO-NOSE FIXATION TAPE by Nikomed U.S.A., Inc. — Product Code CBH

K902896 is an FDA 510(k) premarket notification submitted by Nikomed U.S.A., Inc. for the device "49-610 NIKO-NOSE FIXATION TAPE". The FDA issued a decision of Substantially Equivalent on October 23, 1990. The device falls under product code CBH (Device, Fixation, Tracheal Tube), a Class I device regulated under 21 CFR 868.5770. Nikomed U.S.A., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1990
Date Received
July 3, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Fixation, Tracheal Tube
Device Class
Class I
Regulation Number
868.5770
Review Panel
AN
Submission Type