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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
Predetermined Change
Control Plan Authorized		 No
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