COLIBRI

Tube, Tracheal (w/wo Connector)

ICOR AB

The following data is part of a premarket notification filed by Icor Ab with the FDA for Colibri.

Pre-market Notification Details

• Device ID: K940041
• 510k Number: K940041
• Device Name: COLIBRI
• Classification: Tube, Tracheal (w/wo Connector)
• Applicant: ICOR AB ULVSUNDAVAGEN 178 B Bromma, SE 161 30
• Contact: Andras Gedeon D.sc.
• Correspondent: Andras Gedeon D.sc.; ICOR AB ULVSUNDAVAGEN 178 B Bromma, SE 161 30
• Product Code: BTR
• CFR Regulation Number: 868.5730 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-01-04
• Decision Date: 1994-07-27