The following data is part of a premarket notification filed by Medicus Technologies, Inc. with the FDA for Sickle-2000.
| Device ID | K955719 |
| 510k Number | K955719 |
| Device Name: | SICKLE-2000 |
| Classification | Hemoglobin S |
| Applicant | MEDICUS TECHNOLOGIES, INC. 515 SOUTH FRANKLIN ST. West Chester, PA 19382 |
| Contact | John F O'donnell |
| Correspondent | John F O'donnell MEDICUS TECHNOLOGIES, INC. 515 SOUTH FRANKLIN ST. West Chester, PA 19382 |
| Product Code | GIQ |
| CFR Regulation Number | 864.7415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-18 |
| Decision Date | 1996-08-14 |
| Summary: | summary |