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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 K860315
Device Name NEUROTECH-16 PROGRAM SYSTEM CONTROLLER MODEL 280
Applicant
Neurotech, Inc.
Kevin M. O'Brien
815 Connecticut Ave., NW
Washington,  DC  20006
Applicant Contact & MCKENZIE
Correspondent
Neurotech, Inc.
Kevin M. O'Brien
815 Connecticut Ave., NW
Washington,  DC  20006
Correspondent Contact & MCKENZIE
Regulation Number890.5850
Classification Product Code
IPF  
Date Received01/28/1986
Decision Date 06/17/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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