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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 K951951
Device Name FOCUS MODEL 795 UNIT
Applicant
EMPI
1275 GREY FOX RD.
ST PAUL,  MN  55112
Applicant Contact STACEY MATTSON
Correspondent
EMPI
1275 GREY FOX RD.
ST PAUL,  MN  55112
Correspondent Contact STACEY MATTSON
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Codes
GZI   IPF  
Date Received04/26/1995
Decision Date 05/17/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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