| 510(k) Number |
K861801 |
| Device Name |
WAXTREAT F |
| Applicant |
| Beaute Naturelle International, Inc. |
| 1122 N. Tenth St. |
| Tene Mall - Suite B-C |
|
Mcallen,
TX
78501
|
|
| Applicant Contact |
ROSARIO GARZA |
| Correspondent |
| Beaute Naturelle International, Inc. |
| 1122 N. Tenth St. |
| Tene Mall - Suite B-C |
|
Mcallen,
TX
78501
|
|
| Correspondent Contact |
ROSARIO GARZA |
| Date Received | 05/09/1986 |
| Decision Date | 06/17/1986 |
| Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|