PERIOPATCH

Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

MIS IMPLANTS TECHNOLOGIES LTD.

The following data is part of a premarket notification filed by Mis Implants Technologies Ltd. with the FDA for Periopatch.

Pre-market Notification Details

• Device ID: K110750
• 510k Number: K110750
• Device Name: PERIOPATCH
• Classification: Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
• Applicant: MIS IMPLANTS TECHNOLOGIES LTD. BAR LEV INDUSTRIAL PARK P.O. BOX 7 Bar Lev Industrial Park, IL 20156
• Contact: Iman Khorshid
• Correspondent: Iman Khorshid; MIS IMPLANTS TECHNOLOGIES LTD. BAR LEV INDUSTRIAL PARK P.O. BOX 7 Bar Lev Industrial Park, IL 20156
• Product Code: MGQ
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-03-17
• Decision Date: 2011-04-28
• Summary: summary