TUBE-STAT

Stylet, Tracheal Tube

CONCEPT, INC.

The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Tube-stat.

Pre-market Notification Details

• Device ID: K843490
• 510k Number: K843490
• Device Name: TUBE-STAT
• Classification: Stylet, Tracheal Tube
• Applicant: CONCEPT, INC. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: BSR
• CFR Regulation Number: 868.5790 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-09-06
• Decision Date: 1984-10-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00643169457188	K843490	000
00643169457171	K843490	000