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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K932280
Device Name RAE(R) II TRACHEAL TUBE
Applicant
Mallinckrodt Medical
R.D. #1 Box 1173
Hook Rd.
Argyle,  NY  12809
Applicant Contact LYNN C STIMPSON
Correspondent
Mallinckrodt Medical
R.D. #1 Box 1173
Hook Rd.
Argyle,  NY  12809
Correspondent Contact LYNN C STIMPSON
Regulation Number868.5730
Classification Product Code
BTR  
Date Received05/12/1993
Decision Date 07/08/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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