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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 K970696
Device Name S.P. 100
Applicant
LSI INTL., INC.
8849 BOND
OVERLAND PARK,  KS  66214
Applicant Contact JAMES C LANE
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact GORDON GILLERMAN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received02/25/1997
Decision Date 03/18/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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