UNIVERSAL BONE CEMENT KIT

Cement Obturator

BIODYNAMIC TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Biodynamic Technologies, Inc. with the FDA for Universal Bone Cement Kit.

Pre-market Notification Details

Device IDK931540
510k NumberK931540
Device Name:UNIVERSAL BONE CEMENT KIT
ClassificationCement Obturator
Applicant BIODYNAMIC TECHNOLOGIES, INC. 727 TWENTY-THIRD ST. SOUTH Arlington,  VA  22202
ContactAndrew E Taylor
CorrespondentAndrew E Taylor
BIODYNAMIC TECHNOLOGIES, INC. 727 TWENTY-THIRD ST. SOUTH Arlington,  VA  22202
Product CodeLZN  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-29
Decision Date1994-01-27

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