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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 K945406
Device Name SSV PHONATE(TM) SHILEY SPEAKING VALVE
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
Predetermined Change
Control Plan Authorized		 No
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