RAE II TRACHEAL TUBE

Tube, Tracheal (w/wo Connector)

MALLINCKRODT MEDICAL

The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Rae Ii Tracheal Tube.

Pre-market Notification Details

• Device ID: K941246
• 510k Number: K941246
• Device Name: RAE II TRACHEAL TUBE
• Classification: Tube, Tracheal (w/wo Connector)
• Applicant: MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134
• Contact: James C Webber
• Correspondent: James C Webber; MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134
• Product Code: BTR
• CFR Regulation Number: 868.5730 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-03-15
• Decision Date: 1994-04-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30884522006419	K941246	000
10884522007313	K941246	000
20884522006276	K941246	000
20884522006283	K941246	000
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20884522006405	K941246	000
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20884522007303	K941246	000
10884522007320	K941246	000
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30884521157464	K941246	000
30884521157457	K941246	000
20884521157443	K941246	000
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30884521157471	K941246	000
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50884521157390	K941246	000
60884522006489	K941246	000
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40884522007352	K941246	000
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50884522007298	K941246	000
50884522007304	K941246	000
40884522007314	K941246	000
50884522006475	K941246	000
40884522006416	K941246	000
50884522006406	K941246	000
60884521157403	K941246	000
50884521157413	K941246	000
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50884521157444	K941246	000
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30884522004057	K941246	000
50884522006390	K941246	000
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