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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Needle, Conduction, Anesthetic (W/Wo Introducer)
510(k) Number K050499
Device Name PROBLOC, HN SERIES AND PROLONG, PL SERIES
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 Number868.5150
Classification Product Code
BSP  
Date Received02/28/2005
Decision Date 05/17/2005
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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