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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Connector, Airway (Extension)
510(k) Number K083702
Device Name TRACH-ASSIST
Applicant
Mergenet Medical
24301 Woodsage Dr.
Bonita Springs,  FL  34134 -2958
Applicant Contact PAUL DRYDEN
Correspondent
Mergenet Medical
24301 Woodsage Dr.
Bonita Springs,  FL  34134 -2958
Correspondent Contact PAUL DRYDEN
Regulation Number868.5810
Classification Product Code
BZA  
Date Received12/15/2008
Decision Date 03/05/2009
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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