MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX

Fastener, Fixation, Nondegradable, Soft Tissue

MITEK PRODUCTS

The following data is part of a premarket notification filed by Mitek Products with the FDA for Mitek Absorbable Polydioxanone (pds) H Fix.

Pre-market Notification Details

Device IDK970119
510k NumberK970119
Device Name:MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant MITEK PRODUCTS 60 GLACIER DR. Westwood,  MA  02090
ContactEdward F Kent
CorrespondentEdward F Kent
MITEK PRODUCTS 60 GLACIER DR. Westwood,  MA  02090
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-01-14
Decision Date1998-01-30
Summary:summary

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