Device Classification Name |
device, iontophoresis, other uses
|
510(k) Number |
K133033 |
Device Name |
HIDREX PSP1000 |
Applicant |
HIDREX GMBH |
2611 SHARK CIRCLE |
TEXAS CITY,
TX
77591
|
|
Applicant Contact |
STEFANIE D BANKSTON |
Correspondent |
HIDREX GMBH |
2611 SHARK CIRCLE |
TEXAS CITY,
TX
77591
|
|
Correspondent Contact |
STEFANIE D BANKSTON |
Regulation Number | 890.5525
|
Classification Product Code |
|
Date Received | 09/26/2013 |
Decision Date | 04/08/2015 |
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 |
No
|
Recalls |
CDRH Recalls
|
|
|