The following data is part of a premarket notification filed by Abatement Technologies, Inc. with the FDA for Hepa-care Air Cleaner American Air Filter Air Filtration System Models Hc800f, Hfs800f, Hc800c/ Hfs800c, Hc400c/hfs400c.
| Device ID | K984116 |
| 510k Number | K984116 |
| Device Name: | HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C |
| Classification | Cleaner, Air, Medical Recirculating |
| Applicant | ABATEMENT TECHNOLOGIES, INC. 2220 NORTHMONT PKWY., #100 Duluth, GA 30096 |
| Contact | David Willyard |
| Correspondent | David Willyard ABATEMENT TECHNOLOGIES, INC. 2220 NORTHMONT PKWY., #100 Duluth, GA 30096 |
| Product Code | FRF |
| CFR Regulation Number | 880.5045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-17 |
| Decision Date | 1999-06-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866849000416 | K984116 | 000 |
| 00818261020312 | K984116 | 000 |
| 00818261020305 | K984116 | 000 |
| 00818261020206 | K984116 | 000 |
| 00818261022606 | K984116 | 000 |
| 00818261022309 | K984116 | 000 |
| 00818261022002 | K984116 | 000 |
| 00818261021708 | K984116 | 000 |
| 00818261021401 | K984116 | 000 |
| 00818261021104 | K984116 | 000 |
| 00818261023504 | K984116 | 000 |
| 00818261023207 | K984116 | 000 |
| 00818261022903 | K984116 | 000 |
| 00818261020503 | K984116 | 000 |
| 00818261020510 | K984116 | 000 |
| 00818261020534 | K984116 | 000 |
| 00866849000409 | K984116 | 000 |
| 00818261021036 | K984116 | 000 |
| 00818261021012 | K984116 | 000 |
| 00818261021005 | K984116 | 000 |
| 00818261020916 | K984116 | 000 |
| 00818261020909 | K984116 | 000 |
| 00818261020893 | K984116 | 000 |
| 00818261020817 | K984116 | 000 |
| 00818261020800 | K984116 | 000 |
| 00818261020640 | K984116 | 000 |
| 00818261020619 | K984116 | 000 |
| 00818261020602 | K984116 | 000 |
| 00818261022019 | K984116 | 000 |