POLYTUBE

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

FERRIS MFG. CORP.

The following data is part of a premarket notification filed by Ferris Mfg. Corp. with the FDA for Polytube.

Pre-market Notification Details

• Device ID: K982306
• 510k Number: K982306
• Device Name: POLYTUBE
• Classification: Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
• Applicant: FERRIS MFG. CORP. 16 WEST 300 83RD ST. Burr Ridge, IL 60527
• Contact: Theodore Thorsen
• Correspondent: Theodore Thorsen; FERRIS MFG. CORP. 16 WEST 300 83RD ST. Burr Ridge, IL 60527
• 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: 1998-07-01
• Decision Date: 1998-09-22