SILK

Suture, Nonabsorbable, Silk

TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC.

The following data is part of a premarket notification filed by Trading Consultants And Distributors Intl., Inc. with the FDA for Silk.

Pre-market Notification Details

• Device ID: K993999
• 510k Number: K993999
• Device Name: SILK
• Classification: Suture, Nonabsorbable, Silk
• Applicant: TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC. 157 WINDDANCE DR. Chicago, IL 60046
• Contact: Main M Ghazal
• Correspondent: Main M Ghazal; TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC. 157 WINDDANCE DR. Chicago, IL 60046
• Product Code: GAP
• CFR Regulation Number: 878.5030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-11-24
• Decision Date: 2000-02-04
• Summary: summary