The following data is part of a premarket notification filed by Lectec Corp. with the FDA for Spare Ms 700 Tens Electrode.
Device ID | K881871 |
510k Number | K881871 |
Device Name: | SPARE MS 700 TENS ELECTRODE |
Classification | Electrode, Cutaneous |
Applicant | LECTEC CORP. 10701 RED CIRCLE DR. Minnetonka, MN 55343 |
Contact | Michael J Finley |
Correspondent | Michael J Finley LECTEC CORP. 10701 RED CIRCLE DR. Minnetonka, MN 55343 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-03 |
Decision Date | 1988-06-16 |