DUAL TOP ANCHOR SYSTEM SCREWS

Implant, Endosseous, Root-form

JEIL MEDICAL CORPORATION

The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Dual Top Anchor System Screws.

Pre-market Notification Details

Device IDK033767
510k NumberK033767
Device Name:DUAL TOP ANCHOR SYSTEM SCREWS
ClassificationImplant, Endosseous, Root-form
Applicant JEIL MEDICAL CORPORATION PO BOX 7007 Deerfiled,  IL  60015
ContactDaniel Kamm
CorrespondentDaniel Kamm
JEIL MEDICAL CORPORATION PO BOX 7007 Deerfiled,  IL  60015
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-12-03
Decision Date2004-02-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08809265157328 K033767 000
08809265156789 K033767 000
08809265156796 K033767 000
08806390805322 K033767 000
08809265156277 K033767 000
08809265156291 K033767 000
08809265156802 K033767 000
08809265156819 K033767 000
08809265157304 K033767 000
08809265157311 K033767 000
08809265156284 K033767 000

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