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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vibration Threshold Measurement
510(k) Number K072882
Device Name PAIN VISION, MODEL PS-2100
Applicant
Osachi Co., Ltd.
3027 E. Sunset Rd., Suite 105
Las Vegas,  NV  89120
Applicant Contact JAMES R GREENWOOD
Correspondent
Osachi Co., Ltd.
3027 E. Sunset Rd., Suite 105
Las Vegas,  NV  89120
Correspondent Contact JAMES R GREENWOOD
Regulation Number882.1200
Classification Product Code
LLN  
Date Received10/09/2007
Decision Date 01/08/2009
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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