FLEXGUARD

Powered Laser Surgical Instrument

ALLMED SYSTEMS INC.

The following data is part of a premarket notification filed by Allmed Systems Inc. with the FDA for Flexguard.

Pre-market Notification Details

• Device ID: K070924
• 510k Number: K070924
• Device Name: FLEXGUARD
• Classification: Powered Laser Surgical Instrument
• Applicant: ALLMED SYSTEMS INC. 9232 KLEMETSON DRIVE Pleasanton, CA 94588
• Contact: Peter Allen
• Correspondent: Peter Allen; ALLMED SYSTEMS INC. 9232 KLEMETSON DRIVE Pleasanton, CA 94588
• Product Code: GEX
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-04-03
• Decision Date: 2007-06-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
14250341911579	K070924	000