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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 K102007
Device Name PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC,
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 Received07/16/2010
Decision Date 12/22/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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