SELEC-3

Set, Administration, Intravascular

BIOMEDIX, INC.

The following data is part of a premarket notification filed by Biomedix, Inc. with the FDA for Selec-3.

Pre-market Notification Details

• Device ID: K925645
• 510k Number: K925645
• Device Name: SELEC-3
• Classification: Set, Administration, Intravascular
• Applicant: BIOMEDIX, INC. 23 SOUTLH MAIN ST. P.O. BOX 231 Spencer, IN 47460
• Contact: Duncan Gilmore
• Correspondent: Duncan Gilmore; BIOMEDIX, INC. 23 SOUTLH MAIN ST. P.O. BOX 231 Spencer, IN 47460
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-11-09
• Decision Date: 1993-09-27