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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Uric, Uricase (U.V.)
510(k) Number K971485
Device Name URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
Applicant
TRACE AMERICA, INC.
7260 NORTH WEST 58TH ST.
MIAMI,  FL  33166
Applicant Contact DAVID JOHNSON
Correspondent
TRACE AMERICA, INC.
7260 NORTH WEST 58TH ST.
MIAMI,  FL  33166
Correspondent Contact DAVID JOHNSON
Regulation Number862.1775
Classification Product Code
CDO  
Date Received04/23/1997
Decision Date 05/27/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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