SMART PLUG

Powered Laser Surgical Instrument

HGM, INC.

The following data is part of a premarket notification filed by Hgm, Inc. with the FDA for Smart Plug.

Pre-market Notification Details

• Device ID: K950120
• 510k Number: K950120
• Device Name: SMART PLUG
• Classification: Powered Laser Surgical Instrument
• Applicant: HGM, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104
• Contact: C L Christman
• Correspondent: C L Christman; HGM, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104
• Product Code: GEX
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-01-12
• Decision Date: 1995-08-11