The following data is part of a premarket notification filed by Interpore Intl. with the FDA for Ultracon Ultrafiltrator.
| Device ID | K981253 |
| 510k Number | K981253 |
| Device Name: | ULTRACON ULTRAFILTRATOR |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | INTERPORE INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Contact | Lynn M Rodarti |
| Correspondent | Lynn M Rodarti INTERPORE INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Product Code | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-06 |
| Decision Date | 1998-12-11 |
| Summary: | summary |