The following data is part of a premarket notification filed by Pointcare Technologies Inc. with the FDA for Pointcare Now System.
Device ID | K072869 |
510k Number | K072869 |
Device Name: | POINTCARE NOW SYSTEM |
Classification | Counter, Differential Cell |
Applicant | POINTCARE TECHNOLOGIES INC. 181 CEDAR HILL ST. Marlborough, MA 01752 |
Contact | Maurice N Doire |
Correspondent | Maurice N Doire POINTCARE TECHNOLOGIES INC. 181 CEDAR HILL ST. Marlborough, MA 01752 |
Product Code | GKZ |
CFR Regulation Number | 864.5220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-10-09 |
Decision Date | 2008-01-14 |
Summary: | summary |