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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 K951768
Device Name TEVES ECM PLUS THERMOCOUPLE
Applicant
Advanced Medical Concepts, Inc.
623 39th St. W.
Brandenton,  FL  34205
Applicant Contact LORNA K LINVILLE
Correspondent
Advanced Medical Concepts, Inc.
623 39th St. W.
Brandenton,  FL  34205
Correspondent Contact LORNA K LINVILLE
Regulation Number868.5730
Classification Product Code
BTR  
Date Received04/17/1995
Decision Date 12/15/1995
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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