Device Classification Name |
Media, Electroconductive
|
510(k) Number |
K032239 |
Device Name |
THERA-CREAM, MODEL TCT004 |
Applicant |
PRIZM MEDICAL, INC. |
111 LAUREL RIDGE DRIVE |
ALPHARETTA,
GA
30004
|
|
Applicant Contact |
JULIE STEPHENS |
Correspondent |
PRIZM MEDICAL, INC. |
111 LAUREL RIDGE DRIVE |
ALPHARETTA,
GA
30004
|
|
Correspondent Contact |
JULIE STEPHENS |
Regulation Number | 882.1275
|
Classification Product Code |
|
Date Received | 07/21/2003 |
Decision Date | 07/30/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|