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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, conduction, anesthetic
510(k) Number K072050
Device Name PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CS
Applicant
LIFE-TECH, INC.
4235 GREENBRIAR DR.
STAFFORD,  TX  77477 -3995
Applicant Contact JEFF KASOFF
Correspondent
LIFE-TECH, INC.
4235 GREENBRIAR DR.
STAFFORD,  TX  77477 -3995
Correspondent Contact JEFF KASOFF
Regulation Number868.5120
Classification Product Code
BSO  
Date Received07/26/2007
Decision Date 10/18/2007
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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