| Device Classification Name |
Solvent, Adhesive Tape
|
| 510(k) Number |
K924571 |
| Device Name |
MEDI-SOL |
| Applicant |
| Orange-Sol, Inc. |
| 955 N. Fiesta Blvd., Suite #1 |
|
Gilbert,
AZ
85234
|
|
| Applicant Contact |
GURNEY |
| Correspondent |
| Orange-Sol, Inc. |
| 955 N. Fiesta Blvd., Suite #1 |
|
Gilbert,
AZ
85234
|
|
| Correspondent Contact |
GURNEY |
| Regulation Number | 878.4730 |
| Classification Product Code |
|
| Date Received | 09/10/1992 |
| Decision Date | 04/06/1993 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|