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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lipase hydrolysis/glycerol kinase enzyme, triglycerides
510(k) Number K961477
Device Name TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY
Applicant
TRACE AMERICA, INC.
7260 NORTH WEST 58TH ST.
MIAMI,  FL  33166
Applicant Contact David Johnston
Correspondent
TRACE AMERICA, INC.
7260 NORTH WEST 58TH ST.
MIAMI,  FL  33166
Correspondent Contact David Johnston
Regulation Number862.1705
Classification Product Code
CDT  
Date Received04/18/1996
Decision Date 08/05/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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