| Device Classification Name |
Needle, Aspiration And Injection, Disposable
|
| 510(k) Number |
K873124 |
| Device Name |
ANCHOR BIOPSY NEEDLE |
| Applicant |
| Anchor Products Co. |
| 52 Official Rd. |
|
Addison,
IL
60101
|
|
| Applicant Contact |
ROBERT H THRUN |
| Correspondent |
| Anchor Products Co. |
| 52 Official Rd. |
|
Addison,
IL
60101
|
|
| Correspondent Contact |
ROBERT H THRUN |
| Regulation Number | 878.4800 |
| Classification Product Code |
|
| Date Received | 08/10/1987 |
| Decision Date | 09/08/1987 |
| 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
|