The following data is part of a premarket notification filed by Intertech/ohio with the FDA for Intertech Universal Hydrophobic Filter.
| Device ID | K890346 |
| 510k Number | K890346 |
| Device Name: | INTERTECH UNIVERSAL HYDROPHOBIC FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | INTERTECH/OHIO 5030 TICE ST. Fort Myers, FL 33905 |
| Contact | James W Pope |
| Correspondent | James W Pope INTERTECH/OHIO 5030 TICE ST. Fort Myers, FL 33905 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-23 |
| Decision Date | 1989-03-01 |