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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anesthesia Conduction Kit
510(k) Number K093662
Device Name ECHOBRIGHT
Applicant
LIFE-TECH, INC.
13235 NORTH PROMENADE BLVD.
STAFFORD,  TX  77477
Applicant Contact JEFF KASOFF
Correspondent
LIFE-TECH, INC.
13235 NORTH PROMENADE BLVD.
STAFFORD,  TX  77477
Correspondent Contact JEFF KASOFF
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received11/25/2009
Decision Date 06/24/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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