The following data is part of a premarket notification filed by Medical Equipment Device Specialists with the FDA for Meds-4-inf+.
Device ID | K032055 |
510k Number | K032055 |
Device Name: | MEDS-4-INF+ |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | MEDICAL EQUIPMENT DEVICE SPECIALISTS 9811 W. CHARLESTON #2387 Las Vegas, NV 89117 |
Contact | C. A. Teklinski |
Correspondent | C. A. Teklinski MEDICAL EQUIPMENT DEVICE SPECIALISTS 9811 W. CHARLESTON #2387 Las Vegas, NV 89117 |
Product Code | GZJ |
Subsequent Product Code | IPF |
Subsequent Product Code | LIH |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-07-02 |
Decision Date | 2003-10-03 |