RESORABPLUG

Cement Obturator

SOFAMOR DANEK MFG., INC.

The following data is part of a premarket notification filed by Sofamor Danek Mfg., Inc. with the FDA for Resorabplug.

Pre-market Notification Details

Device IDK920118
510k NumberK920118
Device Name:RESORABPLUG
ClassificationCement Obturator
Applicant SOFAMOR DANEK MFG., INC. 3092 DIRECTORS ROW Memphis,  TN  38131
ContactRichard W Treharne
CorrespondentRichard W Treharne
SOFAMOR DANEK MFG., INC. 3092 DIRECTORS ROW Memphis,  TN  38131
Product CodeLZN  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-01-13
Decision Date1993-02-08

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