The following data is part of a premarket notification filed by Air Safety Ltd with the FDA for Air Safety Hepa And Non-hepa Filters.
| Device ID | K033008 |
| 510k Number | K033008 |
| Device Name: | AIR SAFETY HEPA AND NON-HEPA FILTERS |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | AIR SAFETY LTD 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden AIR SAFETY LTD 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-26 |
| Decision Date | 2004-05-13 |
| Summary: | summary |