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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 K062104
Device Name TALKING TRACH
Applicant
ENGINEERED MEDICAL SYSTEMS, INC.
3460 POINTE CREEK
# 102
BONITA SPRINGS,  FL  34134 -2015
Applicant Contact PAUL DRYDEN
Correspondent
ENGINEERED MEDICAL SYSTEMS, INC.
3460 POINTE CREEK
# 102
BONITA SPRINGS,  FL  34134 -2015
Correspondent Contact PAUL DRYDEN
Regulation Number868.5800
Classification Product Code
BTO  
Date Received07/24/2006
Decision Date 04/20/2007
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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