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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Peripheral, Electric
510(k) Number K954505
Device Name EZ STIM
Applicant
Life-Tech Intl., Inc.
10920 Kinghurst
Houston,  TX  77099
Applicant Contact ANDREW C KYLE
Correspondent
Life-Tech Intl., Inc.
10920 Kinghurst
Houston,  TX  77099
Correspondent Contact ANDREW C KYLE
Regulation Number868.2775
Classification Product Code
KOI  
Date Received09/28/1995
Decision Date 12/10/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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