RETRACTOR

Arthroscope

PHX TECHNOLOGIES CORP.

The following data is part of a premarket notification filed by Phx Technologies Corp. with the FDA for Retractor.

Pre-market Notification Details

• Device ID: K954508
• 510k Number: K954508
• Device Name: RETRACTOR
• Classification: Arthroscope
• Applicant: PHX TECHNOLOGIES CORP. 1032 SHADY OAKS DR., NO. 100 Denton, TX 76205
• Contact: James F Chapel
• Correspondent: James F Chapel; PHX TECHNOLOGIES CORP. 1032 SHADY OAKS DR., NO. 100 Denton, TX 76205
• Product Code: HRX
• CFR Regulation Number: 888.1100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-09-28
• Decision Date: 1995-11-14