OREX

Gauze/sponge, Internal, X-ray Detectable

THANTEX SPECIALTIES, INC.

The following data is part of a premarket notification filed by Thantex Specialties, Inc. with the FDA for Orex.

Pre-market Notification Details

• Device ID: K940764
• 510k Number: K940764
• Device Name: OREX
• Classification: Gauze/sponge, Internal, X-ray Detectable
• Applicant: THANTEX SPECIALTIES, INC. 4320 INTERNATIONAL BLVD, NW Norcross, GA 30093
• Contact: Travis Honeycutt
• Correspondent: Travis Honeycutt; THANTEX SPECIALTIES, INC. 4320 INTERNATIONAL BLVD, NW Norcross, GA 30093
• Product Code: GDY
• CFR Regulation Number: 878.4450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-02-18
• Decision Date: 1994-12-19