The following data is part of a premarket notification filed by Berwick Medical Products, Inc. with the FDA for Prefilled Iec Columns.
| Device ID | K831289 |
| 510k Number | K831289 |
| Device Name: | PREFILLED IEC COLUMNS |
| Classification | Ion-exchange Chromatography |
| Applicant | BERWICK MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DJY |
| CFR Regulation Number | 862.2230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-20 |
| Decision Date | 1983-06-16 |