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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 K965132
Device Name HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES
Applicant
MALLINCKRODT MEDICAL
675 MCDONNELL BLVD.
P.O. BOX 5840
ST. LOUIS,  MO  63134
Applicant Contact MICHAEL B SCHOECK
Correspondent
MALLINCKRODT MEDICAL
675 MCDONNELL BLVD.
P.O. BOX 5840
ST. LOUIS,  MO  63134
Correspondent Contact MICHAEL B SCHOECK
Regulation Number868.5730
Classification Product Code
BTR  
Date Received12/23/1996
Decision Date 03/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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