The following data is part of a premarket notification filed by Epimed International, Inc. with the FDA for Rf Introduction Cannula.
| Device ID | K041021 |
| 510k Number | K041021 |
| Device Name: | RF INTRODUCTION CANNULA |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | EPIMED INTERNATIONAL, INC. 141 SAL LANDRIO DR. CROSSROADS BUSINESS PARK Johnstown, NY 12095 |
| Contact | Christopher B Lake |
| Correspondent | Christopher B Lake EPIMED INTERNATIONAL, INC. 141 SAL LANDRIO DR. CROSSROADS BUSINESS PARK Johnstown, NY 12095 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-20 |
| Decision Date | 2004-09-16 |
| Summary: | summary |