TRAUMA STAND

Tube Mount, X-ray, Diagnostic

XRE CORP.

The following data is part of a premarket notification filed by Xre Corp. with the FDA for Trauma Stand.

Pre-market Notification Details

Device IDK852952
510k NumberK852952
Device Name:TRAUMA STAND
ClassificationTube Mount, X-ray, Diagnostic
Applicant XRE CORP. 300 FOSTER ST. Littleton,  MA  01460
ContactDonna Glencross
CorrespondentDonna Glencross
XRE CORP. 300 FOSTER ST. Littleton,  MA  01460
Product CodeIYB  
CFR Regulation Number892.1770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-07-11
Decision Date1985-09-26

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