SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF

Tube Tracheostomy And Tube Cuff

MALLINCKRODT MEDICAL TPI, INC.

The following data is part of a premarket notification filed by Mallinckrodt Medical Tpi, Inc. with the FDA for Shiley Fenestrated Reusable Inner Cannula, Modif.

Pre-market Notification Details

• Device ID: K930895
• 510k Number: K930895
• Device Name: SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF
• Classification: Tube Tracheostomy And Tube Cuff
• Applicant: MALLINCKRODT MEDICAL TPI, INC. 1595 DEERE AVE. P.O. BOX 19614 Irvine, CA 92714
• Contact: Amy Boucly
• Correspondent: Amy Boucly; MALLINCKRODT MEDICAL TPI, INC. 1595 DEERE AVE. P.O. BOX 19614 Irvine, CA 92714
• Product Code: JOH
• CFR Regulation Number: 868.5800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-02-22
• Decision Date: 1993-07-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
70884522005229	K930895	000
60884522005345	K930895	000
10884522005302	K930895	000
20884522005262	K930895	000