The following data is part of a premarket notification filed by Abracair, Inc. with the FDA for Abracair Air Cleaner, Model Qtz300-60; Abracair Air Cleaner, Model Ti 100-30p.
| Device ID | K052732 |
| 510k Number | K052732 |
| Device Name: | ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P |
| Classification | Purifier, Air, Ultraviolet, Medical |
| Applicant | ABRACAIR, INC. 801 BARRET AVENUE Lousville, KY 40204 |
| Contact | David Changaris |
| Correspondent | David Changaris ABRACAIR, INC. 801 BARRET AVENUE Lousville, KY 40204 |
| Product Code | FRA |
| CFR Regulation Number | 880.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-29 |
| Decision Date | 2006-02-24 |
| Summary: | summary |