ELECTRODELCA

System, X-ray, Photofluorographic

OLDELFT CORP. OF AMERICA

The following data is part of a premarket notification filed by Oldelft Corp. Of America with the FDA for Electrodelca.

Pre-market Notification Details

Device IDK892659
510k NumberK892659
Device Name:ELECTRODELCA
ClassificationSystem, X-ray, Photofluorographic
Applicant OLDELFT CORP. OF AMERICA 2735 DORR AVE. Fairfax,  VA  22031
ContactCharles Pattie
CorrespondentCharles Pattie
OLDELFT CORP. OF AMERICA 2735 DORR AVE. Fairfax,  VA  22031
Product CodeIZG  
CFR Regulation Number892.1730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-13
Decision Date1989-11-21

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