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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 K932592
Device Name BRACE NEUTRALIZER
Applicant
Smith and Nephew Donjoy, Inc.
2777 Loker Ave. W.
Carsbad,  CA  92008
Applicant Contact DAN W MILLER
Correspondent
Smith and Nephew Donjoy, Inc.
2777 Loker Ave. W.
Carsbad,  CA  92008
Correspondent Contact DAN W MILLER
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received05/28/1993
Decision Date 03/18/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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