URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)

Acid, Uric, Uricase (u.v.)

TRACE AMERICA, INC.

The following data is part of a premarket notification filed by Trace America, Inc. with the FDA for Uric Acid - Incorporating Dynamic Stabilization Technology - (dst).

Pre-market Notification Details

Device IDK971485
510k NumberK971485
Device Name:URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
ClassificationAcid, Uric, Uricase (u.v.)
Applicant TRACE AMERICA, INC. 7260 NORTH WEST 58TH ST. Miami,  FL  33166
ContactDavid Johnson
CorrespondentDavid Johnson
TRACE AMERICA, INC. 7260 NORTH WEST 58TH ST. Miami,  FL  33166
Product CodeCDO  
CFR Regulation Number862.1775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-04-23
Decision Date1997-05-27

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