SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES

Tube Tracheostomy And Tube Cuff

MALLINCKRODT MEDICAL

The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Shikey Tracheostomy Tubes And Accessories.

Pre-market Notification Details

• Device ID: K962173
• 510k Number: K962173
• Device Name: SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES
• Classification: Tube Tracheostomy And Tube Cuff
• Applicant: MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134
• Contact: Michael B Schoeck
• Correspondent: Michael B Schoeck; 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: 1996-06-05
• Decision Date: 1996-10-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50884522006604	K962173	000
90884521554821	K962173	000
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