The following data is part of a premarket notification filed by Intertech Resources, Inc. with the FDA for Sterile Inhalation Water Transfer Set.
| Device ID | K882582 |
| 510k Number | K882582 |
| Device Name: | STERILE INHALATION WATER TRANSFER SET |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
| Contact | James W Pope |
| Correspondent | James W Pope INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-22 |
| Decision Date | 1988-09-30 |