FLEXGUIDE

Stylet, Tracheal Tube

SCIENTIFIC SALES INTL., INC.

The following data is part of a premarket notification filed by Scientific Sales Intl., Inc. with the FDA for Flexguide.

Pre-market Notification Details

• Device ID: K940799
• 510k Number: K940799
• Device Name: FLEXGUIDE
• Classification: Stylet, Tracheal Tube
• Applicant: SCIENTIFIC SALES INTL., INC. P.O. BOX 1538 Kalamazoo, MI 49005
• Contact: Nicholas Schmelzer
• Correspondent: Nicholas Schmelzer; SCIENTIFIC SALES INTL., INC. P.O. BOX 1538 Kalamazoo, MI 49005
• Product Code: BSR
• CFR Regulation Number: 868.5790 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-02-22
• Decision Date: 1994-08-18