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 |