Device Classification Name |
Arthroscope
|
510(k) Number |
K001741 |
Device Name |
RADIONICS RF DISC CATHETER ELECTRODE SYSTEM |
Applicant |
RADIONICS, INC. |
22 TERRY AVE. |
BURLINGTON,
MA
01803 -2516
|
|
Applicant Contact |
Kristine Canavan |
Correspondent |
RADIONICS, INC. |
22 TERRY AVE. |
BURLINGTON,
MA
01803 -2516
|
|
Correspondent Contact |
Kristine Canavan |
Regulation Number | 888.1100
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/08/2000 |
Decision Date | 10/23/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|