INTEGRA

Lithotriptor, Extracorporeal Shock-wave, Urological

DIREX SYSTEMS CORP.

The following data is part of a premarket notification filed by Direx Systems Corp. with the FDA for Integra.

Pre-market Notification Details

• Device ID: K053640
• 510k Number: K053640
• Device Name: INTEGRA
• Classification: Lithotriptor, Extracorporeal Shock-wave, Urological
• Applicant: DIREX SYSTEMS CORP. 437 TURNPIKE ST. Canton, MA 02021
• Contact: Larisa Gershtein
• Correspondent: Larisa Gershtein; DIREX SYSTEMS CORP. 437 TURNPIKE ST. Canton, MA 02021
• Product Code: LNS
• CFR Regulation Number: 876.5990 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-12-30
• Decision Date: 2006-03-01
• Summary: summary