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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 K111355
Device Name ECHOBRIGHT
Applicant
LIFE-TECH, INC.
13235 NORTH PROMENADE BLVD.
STAFFORD,  TX  77477
Applicant Contact SKIP RIMER
Correspondent
LIFE-TECH, INC.
13235 NORTH PROMENADE BLVD.
STAFFORD,  TX  77477
Correspondent Contact SKIP RIMER
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received05/16/2011
Decision Date 09/16/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
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