The following data is part of a premarket notification filed by Pointcare Technologies Inc. with the FDA for Flowcare System.
| Device ID | K041882 |
| 510k Number | K041882 |
| Device Name: | FLOWCARE SYSTEM |
| Classification | Counter, Differential Cell |
| Applicant | POINTCARE TECHNOLOGIES INC. 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Cynthia A Sinclair |
| Correspondent | Cynthia A Sinclair POINTCARE TECHNOLOGIES INC. 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-12 |
| Decision Date | 2004-11-23 |
| Summary: | summary |