TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGY

Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

TRACE AMERICA, INC.

The following data is part of a premarket notification filed by Trace America, Inc. with the FDA for Triglycerides Liquid Stable Incorporating Dynamic Stabilisation Technology.

Pre-market Notification Details

Device IDK953971
510k NumberK953971
Device Name:TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGY
ClassificationLipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Applicant TRACE AMERICA, INC. 7260 NORTH WEST 58TH ST. Miami,  FL  33166
ContactDavid Johnston
CorrespondentDavid Johnston
TRACE AMERICA, INC. 7260 NORTH WEST 58TH ST. Miami,  FL  33166
Product CodeCDT  
CFR Regulation Number862.1705 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-08-23
Decision Date1996-04-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00380740135218 K953971 000

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