| Device Classification Name |
Media, Electroconductive
|
| 510(k) Number |
K925466 |
| Device Name |
CONDUCT ALOE GEL, #UP239-8FL. OZ/#UP245 G-1 GALLON |
| Applicant |
| Uni-Patch, Inc. |
| P.O. Box 271 |
| 1313 W. Grant Blvd. |
|
Wabasha,
MN
55981 -0271
|
|
| Applicant Contact |
ALAN I BECKER |
| Correspondent |
| Uni-Patch, Inc. |
| P.O. Box 271 |
| 1313 W. Grant Blvd. |
|
Wabasha,
MN
55981 -0271
|
|
| Correspondent Contact |
ALAN I BECKER |
| Regulation Number | 882.1275 |
| Classification Product Code |
|
| Date Received | 10/29/1992 |
| Decision Date | 08/26/1993 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Neurology
|
| 510k Review Panel |
Neurology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|