The following data is part of a premarket notification filed by Ag Industries with the FDA for Breathing Filter Bacterial/viral, Model Ag7178.
| Device ID | K052087 |
| 510k Number | K052087 |
| Device Name: | BREATHING FILTER BACTERIAL/VIRAL, MODEL AG7178 |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | AG INDUSTRIES 2454 MCMULLEN BOOTH ROAD SUITE 427 Clearwater, FL 33759 |
| Contact | Ian Gordon |
| Correspondent | Ian Gordon AG INDUSTRIES 2454 MCMULLEN BOOTH ROAD SUITE 427 Clearwater, FL 33759 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-02 |
| Decision Date | 2005-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00760120003892 | K052087 | 000 |