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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 K100480
Device Name ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH
Applicant
Vitaltec Corporation
# 58, Fu Chiun St.
Hsin Chu City,  TW 30067
Applicant Contact JEN KE-MIN
Correspondent
Vitaltec Corporation
# 58, Fu Chiun St.
Hsin Chu City,  TW 30067
Correspondent Contact JEN KE-MIN
Regulation Number868.5800
Classification Product Code
BTO  
Date Received02/18/2010
Decision Date 06/11/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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