The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Rf Cannulate.
Device ID | K090955 |
510k Number | K090955 |
Device Name: | SMITH & NEPHEW RF CANNULATE |
Classification | Probe, Radiofrequency Lesion |
Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Contact | Mason W Robbins |
Correspondent | Mason W Robbins SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Product Code | GXI |
CFR Regulation Number | 882.4725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-04-06 |
Decision Date | 2009-07-16 |
Summary: | summary |