The following data is part of a premarket notification filed by M. Imonti And Associates Inc., with the FDA for Endo Trachea Tube Fixation.
| Device ID | K924551 |
| 510k Number | K924551 |
| Device Name: | ENDO TRACHEA TUBE FIXATION |
| Classification | Device, Fixation, Tracheal Tube |
| Applicant | M. IMONTI AND ASSOCIATES INC., 25707 COMPASS WAY San Juan Capistrano, CA 92675 |
| Contact | Maurice Imonti |
| Correspondent | Maurice Imonti M. IMONTI AND ASSOCIATES INC., 25707 COMPASS WAY San Juan Capistrano, CA 92675 |
| Product Code | CBH |
| CFR Regulation Number | 868.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-09 |
| Decision Date | 1992-12-08 |