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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Suction, Tracheobronchial
510(k) Number K031997
Device Name MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM
Applicant
MALLINCKRODT DAR S.R.L.
VIA G.BOVE, 2/4/6/8
MIRANDOLA (MODENA),  IT 41037
Applicant Contact GIUSEPPE TOMASINI
Correspondent
MALLINCKRODT DAR S.R.L.
VIA G.BOVE, 2/4/6/8
MIRANDOLA (MODENA),  IT 41037
Correspondent Contact GIUSEPPE TOMASINI
Regulation Number868.6810
Classification Product Code
BSY  
Date Received06/27/2003
Decision Date 11/25/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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