N-TERFACE

Dressing, Wound And Burn, Occlusive

WINFIELD LABORATORIES, INC.

The following data is part of a premarket notification filed by Winfield Laboratories, Inc. with the FDA for N-terface.

Pre-market Notification Details

• Device ID: K973538
• 510k Number: K973538
• Device Name: N-TERFACE
• Classification: Dressing, Wound And Burn, Occlusive
• Applicant: WINFIELD LABORATORIES, INC. 10488 BROCKWOOD RD. Dallas, TX 75238
• Contact: Gary W Cummings
• Correspondent: Gary W Cummings; WINFIELD LABORATORIES, INC. 10488 BROCKWOOD RD. Dallas, TX 75238
• Product Code: MGP
• 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: 1997-09-18
• Decision Date: 1997-12-16
• Summary: summary