The following data is part of a premarket notification filed by Lsi Intl., Inc. with the FDA for Ms300.
Device ID | K984021 |
510k Number | K984021 |
Device Name: | MS300 |
Classification | Stimulator, Muscle, Powered |
Applicant | LSI INTL., INC. 8849 BOND Overland Park, KS 66214 |
Contact | James C Lane |
Correspondent | James C Lane LSI INTL., INC. 8849 BOND Overland Park, KS 66214 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-11-12 |
Decision Date | 1999-01-28 |