DSM Biomedical DPR Cable

Cerclage, Fixation

DSM BIOMEDICAL

The following data is part of a premarket notification filed by Dsm Biomedical with the FDA for Dsm Biomedical Dpr Cable.

Pre-market Notification Details

Device IDK143716
510k NumberK143716
Device Name:DSM Biomedical DPR Cable
ClassificationCerclage, Fixation
Applicant DSM BIOMEDICAL 735 PENNSYLVANIA DRIVE Exton,  PA  19341
ContactLori Burns
CorrespondentTom Maguire
DSM BIOMEDICAL 735 PENNSYLVANIA DRIVE Exton,  PA  19341
Product CodeJDQ  
CFR Regulation Number888.3010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-29
Decision Date2015-10-29
Summary:summary

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