The following data is part of a premarket notification filed by Rex Medical with the FDA for 15.5f Hemo-stream Hemodialysis Catheter Set.
| Device ID | K071422 |
| 510k Number | K071422 |
| Device Name: | 15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | REX MEDICAL 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk REX MEDICAL 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-22 |
| Decision Date | 2007-08-22 |
| Summary: | summary |