The following data is part of a premarket notification filed by Quantic Biomedical, Inc. with the FDA for Ultracon Ultrafiltrator.
| Device ID | K971710 |
| 510k Number | K971710 |
| Device Name: | ULTRACON ULTRAFILTRATOR |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | QUANTIC BIOMEDICAL, INC. 810 "E" ST. San Rafael, CA 94901 -2819 |
| Contact | Andrew G Hood |
| Correspondent | Andrew G Hood QUANTIC BIOMEDICAL, INC. 810 "E" ST. San Rafael, CA 94901 -2819 |
| Product Code | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-08 |
| Decision Date | 1998-02-27 |
| Summary: | summary |