| Device Classification Name |
Epilator, High Frequency, Needle-Type
|
| 510(k) Number |
K880553 |
| Device Name |
ELECTRONIC EPILATOR |
| Applicant |
| Clareblend, Inc. |
| 13026 San Fernando Rd. |
|
Sylmar,
CA
91342
|
|
| Applicant Contact |
MARGARET M SMITH |
| Correspondent |
| Clareblend, Inc. |
| 13026 San Fernando Rd. |
|
Sylmar,
CA
91342
|
|
| Correspondent Contact |
MARGARET M SMITH |
| Regulation Number | 878.5350 |
| Classification Product Code |
|
| Date Received | 02/09/1988 |
| Decision Date | 02/29/1988 |
| 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
|
|
|