The following data is part of a premarket notification filed by Cosman Medical, Inc. with the FDA for Cosman Csk Rf Cannula; Cosman Rfk Rf Cannula.
Device ID | K060799 |
510k Number | K060799 |
Device Name: | COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA |
Classification | Probe, Radiofrequency Lesion |
Applicant | COSMAN MEDICAL, INC. 76 CAMBRIDGE ST. Burlington, MA 01803 |
Contact | Michael Arnold |
Correspondent | Michael Arnold COSMAN MEDICAL, INC. 76 CAMBRIDGE ST. Burlington, MA 01803 |
Product Code | GXI |
CFR Regulation Number | 882.4725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-03-24 |
Decision Date | 2006-05-02 |
Summary: | summary |