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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
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