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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube tracheostomy and tube cuff
510(k) Number K954749
Device Name MALLINCKRODT SHILEY 15MM CAP
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 Number868.5800
Classification Product Code
JOH  
Date Received10/16/1995
Decision Date 01/24/1996
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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