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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 K936224
Device Name REUSABLE CANNULA TRACHEOSTOMY TUBES, MODIFIED HEADS
Applicant
MALLINCKRODT MEDICAL TPI, INC.
1595 DEERE AVE.
P.O. BOX 19614
IRVINE,  CA  92714
Applicant Contact AMY BOUCLY
Correspondent
MALLINCKRODT MEDICAL TPI, INC.
1595 DEERE AVE.
P.O. BOX 19614
IRVINE,  CA  92714
Correspondent Contact AMY BOUCLY
Regulation Number868.5800
Classification Product Code
JOH  
Date Received12/07/1993
Decision Date 08/30/1994
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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