| Device Classification Name |
Needle, Acupuncture, Single Use
|
| 510(k) Number |
K001718 |
| Device Name |
MILLENNIA ACUPUNCTURE NEEDLE |
| Applicant |
| United Pacific Co., Ltd. |
| 219 S. Raymond Ave. |
|
Alhambra,
CA
91801
|
|
| Applicant Contact |
DANIEL YE HUA |
| Correspondent |
| United Pacific Co., Ltd. |
| 219 S. Raymond Ave. |
|
Alhambra,
CA
91801
|
|
| Correspondent Contact |
DANIEL YE HUA |
| Regulation Number | 880.5580 |
| Classification Product Code |
|
| Date Received | 06/05/2000 |
| Decision Date | 06/21/2000 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|