CUFFED TRACHEAL TUBE (MULTIPLE)

Tube, Tracheal (w/wo Connector)

MALLINCKRODT CRITICAL CARE

The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Cuffed Tracheal Tube (multiple).

Pre-market Notification Details

• Device ID: K871204
• 510k Number: K871204
• Device Name: CUFFED TRACHEAL TUBE (MULTIPLE)
• Classification: Tube, Tracheal (w/wo Connector)
• Applicant: MALLINCKRODT CRITICAL CARE HOOK RD. Argyle, NY 12809
• Contact: E Wiegert,phd
• Correspondent: E Wiegert,phd; MALLINCKRODT CRITICAL CARE HOOK RD. Argyle, NY 12809
• Product Code: BTR
• CFR Regulation Number: 868.5730 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-03-25
• Decision Date: 1987-04-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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