The following data is part of a premarket notification filed by Xanacare Technologies, Llc with the FDA for Combocare 2000.
Device ID | K083202 |
510k Number | K083202 |
Device Name: | COMBOCARE 2000 |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | XANACARE TECHNOLOGIES, LLC 13605 W. 7TH AVE. Golden, CO 80401 |
Contact | Robert N Clark |
Correspondent | Robert N Clark XANACARE TECHNOLOGIES, LLC 13605 W. 7TH AVE. Golden, CO 80401 |
Product Code | GZJ |
Subsequent Product Code | ILY |
Subsequent Product Code | ISA |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-10-30 |
Decision Date | 2008-12-15 |
Summary: | summary |