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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 K082772
Device Name STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC19100, SPC19150, SPC18050,SPC18100,SPC18150
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 Received09/22/2008
Decision Date 02/09/2009
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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