ENDOGRIP

Tube, Tracheal (w/wo Connector)

BIOMEDIX, INC.

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

Pre-market Notification Details

• Device ID: K926498
• 510k Number: K926498
• Device Name: ENDOGRIP
• Classification: Tube, Tracheal (w/wo Connector)
• 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: BTR
• CFR Regulation Number: 868.5730 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-12-29
• Decision Date: 1993-04-07