POINTCARE NOW SYSTEM

Counter, Differential Cell

POINTCARE TECHNOLOGIES INC.

The following data is part of a premarket notification filed by Pointcare Technologies Inc. with the FDA for Pointcare Now System.

Pre-market Notification Details

Device IDK072869
510k NumberK072869
Device Name:POINTCARE NOW SYSTEM
ClassificationCounter, Differential Cell
Applicant POINTCARE TECHNOLOGIES INC. 181 CEDAR HILL ST. Marlborough,  MA  01752
ContactMaurice N Doire
CorrespondentMaurice N Doire
POINTCARE TECHNOLOGIES INC. 181 CEDAR HILL ST. Marlborough,  MA  01752
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-10-09
Decision Date2008-01-14
Summary:summary

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