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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K041917
Device Name PLASIATEK ACTUATOR
Applicant
Plasiatek, LLC
10560 Wayzata Blvd.
Minneapolis,  MN  55305
Applicant Contact PAUL PESEK
Correspondent
Plasiatek, LLC
10560 Wayzata Blvd.
Minneapolis,  MN  55305
Correspondent Contact PAUL PESEK
Regulation Number868.5730
Classification Product Code
BTR  
Date Received07/16/2004
Decision Date 01/07/2005
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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