| Device Classification Name |
Pump, Portable, Aspiration (Manual Or Powered)
|
| 510(k) Number |
K870094 |
| Device Name |
BUNN MODEL 530 ASPIRATOR |
| Applicant |
| The John Bunn Co. |
| 290 Creekside Dr. |
|
Tonawanda,
NY
14150
|
|
| Applicant Contact |
DENNIS KENYON |
| Correspondent |
| The John Bunn Co. |
| 290 Creekside Dr. |
|
Tonawanda,
NY
14150
|
|
| Correspondent Contact |
DENNIS KENYON |
| Regulation Number | 878.4780 |
| Classification Product Code |
|
| Date Received | 01/09/1987 |
| Decision Date | 03/06/1987 |
| 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
|