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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
Predetermined Change
Control Plan Authorized		 No
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