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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 K073438
Device Name PROSTIM 1000/2000
Applicant
BIO PROTECH, INC.
1676 VILLAGE GREEN SUITE A
CROFTON,  MD  21114
Applicant Contact E.J. Smith
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received12/07/2007
Decision Date 02/07/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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