The following data is part of a premarket notification filed by Spembly Medical Ltd. with the FDA for Spembly 9000 & 9300.
Device ID | K802063 |
510k Number | K802063 |
Device Name: | SPEMBLY 9000 & 9300 |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | SPEMBLY MEDICAL LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-08-26 |
Decision Date | 1980-10-03 |