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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
Predetermined Change
Control Plan Authorized		 No
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