S.P. 100

Stimulator, Nerve, Transcutaneous, For Pain Relief

LSI INTL., INC.

The following data is part of a premarket notification filed by Lsi Intl., Inc. with the FDA for S.p. 100.

Pre-market Notification Details

Device IDK970696
510k NumberK970696
Device Name:S.P. 100
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant LSI INTL., INC. 8849 BOND Overland Park,  KS  66214
ContactJames C Lane
CorrespondentGordon Gillerman
UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook,  IL  60062
Product CodeGZJ  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received1997-02-25
Decision Date1997-03-18

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