The following data is part of a premarket notification filed by Interpore Cross Intl. with the FDA for Ultraconcentrator System.
| Device ID | K011148 |
| 510k Number | K011148 |
| Device Name: | ULTRACONCENTRATOR SYSTEM |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Contact | Prosie Rey-fessler |
| Correspondent | Prosie Rey-fessler INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Product Code | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-16 |
| Decision Date | 2001-06-13 |