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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K952273
Device Name HANDMASTER NMS1
Applicant
Neuromusclar Electrical Stimulation Systems, Ltd.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Neuromusclar Electrical Stimulation Systems, Ltd.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number890.5850
Classification Product Code
IPF  
Date Received05/15/1995
Decision Date 05/23/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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