The following data is part of a premarket notification filed by Med-tek Corp. with the FDA for Bacterial Filter.
| Device ID | K894978 |
| 510k Number | K894978 |
| Device Name: | BACTERIAL FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | MED-TEK CORP. 6685 NORTH SIDNEY PLACE Glendale, WI 53209 |
| Contact | Alan E Whitmarsh |
| Correspondent | Alan E Whitmarsh MED-TEK CORP. 6685 NORTH SIDNEY PLACE Glendale, WI 53209 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-03 |
| Decision Date | 1989-11-02 |