The following data is part of a premarket notification filed by Idemsa with the FDA for Idemsa Hemophan Hollow Fiber Dialyzers.
| Device ID | K991908 |
| 510k Number | K991908 |
| Device Name: | IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | IDEMSA 1600 STEWART AVE. Westbury, NY 11590 |
| Contact | Leon Lachman |
| Correspondent | Leon Lachman IDEMSA 1600 STEWART AVE. Westbury, NY 11590 |
| Product Code | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-07 |
| Decision Date | 2000-04-17 |
| Summary: | summary |