510(k) K902896
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