EXAM-PACS

System, Image Processing, Radiological

COACTIV, LLC

The following data is part of a premarket notification filed by Coactiv, Llc with the FDA for Exam-pacs.

Pre-market Notification Details

Device IDK042647
510k NumberK042647
Device Name:EXAM-PACS
ClassificationSystem, Image Processing, Radiological
Applicant COACTIV, LLC 1100 LAKEVIEW BLVD Denton,  TX  76208
ContactCarl Alletto
CorrespondentNed Devine
ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids,  MI  49548
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2004-09-28
Decision Date2004-10-07
Summary:summary

Trademark Results [EXAM-PACS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EXAM-PACS
EXAM-PACS
78342259 2916419 Live/Registered
Coactiv, LLC
2003-12-17

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