The following data is part of a premarket notification filed by Technomed Europe with the FDA for Disposable And Reusable Concentric Needle Electrodes,disposable And Reusable Subdermal Needle Electrodes,.
Device ID | K130136 |
510k Number | K130136 |
Device Name: | DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES, |
Classification | Electrode, Needle |
Applicant | TECHNOMED EUROPE AMERIKALAAN 71 Maastricht Airport, NL 6199 Ae |
Contact | Pierre Vreuls |
Correspondent | Pierre Vreuls TECHNOMED EUROPE AMERIKALAAN 71 Maastricht Airport, NL 6199 Ae |
Product Code | GXZ |
CFR Regulation Number | 882.1350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-01-18 |
Decision Date | 2013-07-19 |
Summary: | summary |