The following data is part of a premarket notification filed by Nikomed U.s.a., Inc. with the FDA for 49-610 Niko-nose Fixation Tape.
| Device ID | K902896 |
| 510k Number | K902896 |
| Device Name: | 49-610 NIKO-NOSE FIXATION TAPE |
| Classification | Device, Fixation, Tracheal Tube |
| Applicant | NIKOMED U.S.A., INC. 1300 AIRPORT RD, STE C North Brunswick, NJ 08902 |
| Contact | Donald Epstein |
| Correspondent | Donald Epstein NIKOMED U.S.A., INC. 1300 AIRPORT RD, STE C North Brunswick, NJ 08902 |
| Product Code | CBH |
| CFR Regulation Number | 868.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-03 |
| Decision Date | 1990-10-23 |