Device Classification Name |
Probe, Radiofrequency Lesion
|
510(k) Number |
K041021 |
Device Name |
RF INTRODUCTION CANNULA |
Applicant |
EPIMED INTERNATIONAL, INC. |
141 SAL LANDRIO DR. |
CROSSROADS BUSINESS PARK |
JOHNSTOWN,
NY
12095
|
|
Applicant Contact |
CHRISTOPHER B LAKE |
Correspondent |
EPIMED INTERNATIONAL, INC. |
141 SAL LANDRIO DR. |
CROSSROADS BUSINESS PARK |
JOHNSTOWN,
NY
12095
|
|
Correspondent Contact |
CHRISTOPHER B LAKE |
Regulation Number | 882.4725
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/20/2004 |
Decision Date | 09/16/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|