DUET

Prosthesis, Adhesive, External

TRULIFE LTD.

The following data is part of a premarket notification filed by Trulife Ltd. with the FDA for Duet.

Pre-market Notification Details

• Device ID: K934970
• 510k Number: K934970
• Device Name: DUET
• Classification: Prosthesis, Adhesive, External
• Applicant: TRULIFE LTD. 3 COOKSTOWN INDUSTRIAL ESTATE TALLAGHT Dublin 24, IE
• Contact: Jean Twohig
• Correspondent: Jean Twohig; TRULIFE LTD. 3 COOKSTOWN INDUSTRIAL ESTATE TALLAGHT Dublin 24, IE
• Product Code: GBJ
• CFR Regulation Number: 878.3750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-10-18
• Decision Date: 1993-12-10