The following data is part of a premarket notification filed by Ag Industries with the FDA for Compressor Filter, Models Ag1038831, Hcf100,bf900,bf910,bf950, Ll201, Ll202, Ll205, Bacteria Filter.
| Device ID | K091363 |
| 510k Number | K091363 |
| Device Name: | COMPRESSOR FILTER, MODELS AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205, BACTERIA FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | AG INDUSTRIES 1705. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746 |
| Contact | Ian Gordon |
| Correspondent | Ian Gordon AG INDUSTRIES 1705. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-08 |
| Decision Date | 2010-02-04 |
| Summary: | summary |