The following data is part of a premarket notification filed by Air Safety Ltd with the FDA for Air Safety Model 3000/06 Filter Hepa Reusable.
| Device ID | K050953 |
| 510k Number | K050953 |
| Device Name: | AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE |
| 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 | 2005-04-15 |
| Decision Date | 2005-06-29 |
| Summary: | summary |