HYCOAT

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

THE HYMED GROUP CORP.

The following data is part of a premarket notification filed by The Hymed Group Corp. with the FDA for Hycoat.

Pre-market Notification Details

• Device ID: K960686
• 510k Number: K960686
• Device Name: HYCOAT
• Classification: Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
• Applicant: THE HYMED GROUP CORP. 1890 BUCKNELL DR. Bethlehem, PA 18015
• Contact: George D Petito
• Correspondent: George D Petito; THE HYMED GROUP CORP. 1890 BUCKNELL DR. Bethlehem, PA 18015
• Product Code: MGQ
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent For Some Indications (SN)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-02-20
• Decision Date: 1996-08-12