The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Rf Electrodes And Cannulae.
Device ID | K032406 |
510k Number | K032406 |
Device Name: | STRYKER RF ELECTRODES AND CANNULAE |
Classification | Probe, Radiofrequency Lesion |
Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
Contact | Nicole Petty |
Correspondent | Nicole Petty STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
Product Code | GXI |
CFR Regulation Number | 882.4725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-08-04 |
Decision Date | 2004-04-01 |
Summary: | summary |