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 ID: K062081
• 510k Number: K062081
• Device Name: LITHOGOLD
• Classification: Lithotriptor, Extracorporeal Shock-wave, Urological
• Applicant: TISSUE REGENERATION TECHNOLOGIES, INC. 719 A ST., NE Washington, DC 20002
• Contact: Cherita James
• Correspondent: Cherita James; TISSUE REGENERATION TECHNOLOGIES, INC. 719 A ST., NE Washington, DC 20002
• Product Code: LNS
• CFR Regulation Number: 876.5990 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-07-21
• Decision Date: 2006-11-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
4260484573018	K062081	000