Device Classification Name |
probe, radiofrequency lesion
|
510(k) Number |
K092337 |
Device Name |
PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS |
Applicant |
BAYLIS MEDICAL CO., INC. |
2645 MATHESON BLVD. E |
MISSISSAUGA, ONTARIO,
CA
L4W 5S4
|
|
Applicant Contact |
MEGHAL KHAKHAR |
Correspondent |
BAYLIS MEDICAL CO., INC. |
2645 MATHESON BLVD. E |
MISSISSAUGA, ONTARIO,
CA
L4W 5S4
|
|
Correspondent Contact |
MEGHAL KHAKHAR |
Regulation Number | 882.4725
|
Classification Product Code |
|
Date Received | 08/04/2009 |
Decision Date | 10/16/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|