The following data is part of a premarket notification filed by Atlantic Wholesale, Inc. with the FDA for Zavos Disposable Filtration Column (zdfc).
| Device ID | K890997 |
| 510k Number | K890997 |
| Device Name: | ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC) |
| Classification | Resins, Ion-exchange |
| Applicant | ATLANTIC WHOLESALE, INC. POST OFFICE BOX 76 Alpharetta, GA 30239 |
| Contact | Eric E Gilmer |
| Correspondent | Eric E Gilmer ATLANTIC WHOLESALE, INC. POST OFFICE BOX 76 Alpharetta, GA 30239 |
| Product Code | KEA |
| CFR Regulation Number | 862.2230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-27 |
| Decision Date | 1989-03-28 |