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 |