The following data is part of a premarket notification filed by Amicon, Inc. with the FDA for Amicon Vitafiber Flo-path Biorect/vls Cell Cult Sy.
| Device ID | K892645 |
| 510k Number | K892645 |
| Device Name: | AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY |
| Classification | System, Suspension, Cell Culture |
| Applicant | AMICON, INC. 17 CHERRY HILL DR. Danvers, MA 01923 |
| Contact | James M Delaney |
| Correspondent | James M Delaney AMICON, INC. 17 CHERRY HILL DR. Danvers, MA 01923 |
| Product Code | KJF |
| CFR Regulation Number | 864.2240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-12 |
| Decision Date | 1989-06-13 |