F/C/W TUBESTAND

Tube Mount, X-ray, Diagnostic

ACOMA MEDICAL IMAGING, INC.

The following data is part of a premarket notification filed by Acoma Medical Imaging, Inc. with the FDA for F/c/w Tubestand.

Pre-market Notification Details

Device IDK941017
510k NumberK941017
Device Name:F/C/W TUBESTAND
ClassificationTube Mount, X-ray, Diagnostic
Applicant ACOMA MEDICAL IMAGING, INC. 150 CHADDICK DR. Wheeling,  IL  60090
ContactJames Lambrecht
CorrespondentJames Lambrecht
ACOMA MEDICAL IMAGING, INC. 150 CHADDICK DR. Wheeling,  IL  60090
Product CodeIYB  
CFR Regulation Number892.1770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-03-03
Decision Date1994-07-29

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