The following data is part of a premarket notification filed by Lsi Intl., Inc. with the FDA for S.p. 100.
Device ID | K970696 |
510k Number | K970696 |
Device Name: | S.P. 100 |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | LSI INTL., INC. 8849 BOND Overland Park, KS 66214 |
Contact | James C Lane |
Correspondent | Gordon Gillerman UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 1997-02-25 |
Decision Date | 1997-03-18 |