MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE

Tube Tracheostomy And Tube Cuff

MALLINCKRODT MEDICAL

The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Mallinckrodt Shiley Neonatal, Pediatric, Long Pediatric Tracheostomy Tube.

Pre-market Notification Details

• Device ID: K945513
• 510k Number: K945513
• Device Name: MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE
• Classification: Tube Tracheostomy And Tube Cuff
• Applicant: MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134
• Contact: Robert F Ingham
• Correspondent: Robert F Ingham; MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134
• Product Code: JOH
• CFR Regulation Number: 868.5800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-11-09
• Decision Date: 1995-01-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10884521555259	K945513	000
90884521554555	K945513	000
90884521554593	K945513	000
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30884521112890	K945513	000
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20884522026748	K945513	000