| Device Classification Name |
Device, Iontophoresis, Other Uses
|
| 510(k) Number |
K913601 |
| Device Name |
MICROPHOR |
| Applicant |
| Life-Tech Intl., Inc. |
| P.O. Box 36221 |
|
Houston,
TX
77236
|
|
| Applicant Contact |
ALFRED C COATS |
| Correspondent |
| Life-Tech Intl., Inc. |
| P.O. Box 36221 |
|
Houston,
TX
77236
|
|
| Correspondent Contact |
ALFRED C COATS |
| Regulation Number | 890.5525 |
| Classification Product Code |
|
| Date Received | 08/13/1991 |
| Decision Date | 07/15/1994 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Physical Medicine
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|