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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 (w/wo connector)
510(k) Number K945407
Device Name SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT
Applicant
MALLINCKRODT MEDICAL TPI, INC.
1595 DEERE AVE.
P.O. BOX 19614
IRVINE,  CA  92714
Applicant Contact ROBERT F INGHAM
Correspondent
MALLINCKRODT MEDICAL TPI, INC.
1595 DEERE AVE.
P.O. BOX 19614
IRVINE,  CA  92714
Correspondent Contact ROBERT F INGHAM
Regulation Number868.5800
Classification Product Code
BTO  
Date Received11/03/1994
Decision Date 02/27/1995
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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