Device Classification Name |
device, iontophoresis, other uses
|
510(k) Number |
K031053 |
Device Name |
SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7 |
Applicant |
SELECTIVE MED COMPONENTS, INC. |
201 WEST HIGH ST. |
MOUNT VERNON,
OH
43050
|
|
Applicant Contact |
RICHARD J FISHER |
Correspondent |
SELECTIVE MED COMPONENTS, INC. |
201 WEST HIGH ST. |
MOUNT VERNON,
OH
43050
|
|
Correspondent Contact |
RICHARD J FISHER |
Regulation Number | 890.5525
|
Classification Product Code |
|
Date Received | 04/02/2003 |
Decision Date | 05/20/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
Recalls |
CDRH Recalls
|
|
|