TANDA RESTORE, MODEL PTSCS

Lamp, Infrared, Therapeutic Heating

PHAROS LIFE CORPORATION

The following data is part of a premarket notification filed by Pharos Life Corporation with the FDA for Tanda Restore, Model Ptscs.

Pre-market Notification Details

Device IDK090008
510k NumberK090008
Device Name:TANDA RESTORE, MODEL PTSCS
ClassificationLamp, Infrared, Therapeutic Heating
Applicant PHAROS LIFE CORPORATION 11-380 JAMIESON PKWY Cambridge, Ontario,  CA N3c 4n4
ContactPhil Cuscuna
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeILY  
CFR Regulation Number890.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2009-01-02
Decision Date2009-10-15
Summary:summary

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