Device Classification Name |
Catheter, Intravascular, Diagnostic
|
510(k) Number |
K002416 |
Device Name |
GOLDEN-RULE SCALING CATHETER |
Applicant |
MEDICAL DEVICE TECHNOLOGIES, INC. |
3600 SW 47TH AVENUE |
GAINESVILLE,
FL
32608
|
|
Applicant Contact |
KARL SWARTZ |
Correspondent |
MEDICAL DEVICE TECHNOLOGIES, INC. |
3600 SW 47TH AVENUE |
GAINESVILLE,
FL
32608
|
|
Correspondent Contact |
KARL SWARTZ |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 08/08/2000 |
Decision Date | 09/11/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|