DCAS I

System, Image Processing, Radiological

GP&P CO., LTD.

The following data is part of a premarket notification filed by Gp&p Co., Ltd. with the FDA for Dcas I.

Pre-market Notification Details

Device IDK140869
510k NumberK140869
Device Name:DCAS I
ClassificationSystem, Image Processing, Radiological
Applicant GP&P CO., LTD. 12226 WASHINGTON LANE Parker,  AZ  85344
ContactCharlie Mack
CorrespondentCharlie Mack
GP&P CO., LTD. 12226 WASHINGTON LANE Parker,  AZ  85344
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-03
Decision Date2014-07-03
Summary:summary

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