CLEAR-IT ANTI-FOG, MODEL PS003

Anti Fog Solution And Accessories, Endoscopy

PRESERVATION SOLUTIONS, INC.

The following data is part of a premarket notification filed by Preservation Solutions, Inc. with the FDA for Clear-it Anti-fog, Model Ps003.

Pre-market Notification Details

Device IDK022826
510k NumberK022826
Device Name:CLEAR-IT ANTI-FOG, MODEL PS003
ClassificationAnti Fog Solution And Accessories, Endoscopy
Applicant PRESERVATION SOLUTIONS, INC. 8300 W. 110TH ST. Bloomington,  MN  55438
ContactJohn R Dalpee
CorrespondentJohn R Dalpee
PRESERVATION SOLUTIONS, INC. 8300 W. 110TH ST. Bloomington,  MN  55438
Product CodeOCT  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-08-26
Decision Date2002-10-09
Summary:summary

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