LITHOGOLD

Lithotriptor, Extracorporeal Shock-wave, Urological

TISSUE REGENERATION TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Tissue Regeneration Technologies, Inc. with the FDA for Lithogold.

Pre-market Notification Details

Device IDK062081
510k NumberK062081
Device Name:LITHOGOLD
ClassificationLithotriptor, Extracorporeal Shock-wave, Urological
Applicant TISSUE REGENERATION TECHNOLOGIES, INC. 719 A ST., NE Washington,  DC  20002
ContactCherita James
CorrespondentCherita James
TISSUE REGENERATION TECHNOLOGIES, INC. 719 A ST., NE Washington,  DC  20002
Product CodeLNS  
CFR Regulation Number876.5990 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-21
Decision Date2006-11-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
4260484573018 K062081 000

Trademark Results [LITHOGOLD]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LITHOGOLD
LITHOGOLD
78693252 not registered Dead/Abandoned
TISSUE REGENERATION TECHNOLOGIES, LLC
2005-08-16
LITHOGOLD
LITHOGOLD
78673531 3473725 Live/Registered
TISSUE REGENERATION TECHNOLOGIES, LLC
2005-07-19

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