HAND HELD DENTAL X-RAY DEVICE

System, X-ray, Mobile

DEPT. OF THE ARMY

The following data is part of a premarket notification filed by Dept. Of The Army with the FDA for Hand Held Dental X-ray Device.

Pre-market Notification Details

Device IDK934818
510k NumberK934818
Device Name:HAND HELD DENTAL X-RAY DEVICE
ClassificationSystem, X-ray, Mobile
Applicant DEPT. OF THE ARMY 5109 LEESBURG PIKE Falls Church,  VA  22041
ContactDale G Vander Hamm
CorrespondentDale G Vander Hamm
DEPT. OF THE ARMY 5109 LEESBURG PIKE Falls Church,  VA  22041
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-10-07
Decision Date1994-01-24

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