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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 K062003
Device Name NEURO WAVE 6
Applicant
Lhasa Oms, Inc.
230 Libbey Pkwy.
Weymouth,  MA  02189
Applicant Contact MARK W SHEEHAN
Correspondent
Lhasa Oms, Inc.
230 Libbey Pkwy.
Weymouth,  MA  02189
Correspondent Contact MARK W SHEEHAN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received07/17/2006
Decision Date 09/19/2007
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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