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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, Transcutaneous, For Pain Relief
510(k) Number K041172
Device Name BASBA E-MACHINE
Applicant
Basba, Inc.
12101 Cullen Blvd., #A
Houston,  TX 
Applicant Contact M. JOYCE HEINRICH
Correspondent
Basba, Inc.
12101 Cullen Blvd., #A
Houston,  TX 
Correspondent Contact M. JOYCE HEINRICH
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received05/04/2004
Decision Date 11/18/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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