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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
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