The following data is part of a premarket notification filed by Inhalation Plastics with the FDA for Sterilization Of Devices By Radiation.
| Device ID | K874659 |
| 510k Number | K874659 |
| Device Name: | STERILIZATION OF DEVICES BY RADIATION |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | INHALATION PLASTICS 7790 N. MERRIMAC Chicago, IL 60648 |
| Contact | James Lekkas |
| Correspondent | James Lekkas INHALATION PLASTICS 7790 N. MERRIMAC Chicago, IL 60648 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-20 |
| Decision Date | 1988-02-02 |