| Device Classification Name |
Pump, Portable, Aspiration (Manual Or Powered)
|
| 510(k) Number |
K862751 |
| Device Name |
USA ASPIRATOR |
| Applicant |
| U. S. A. Medical Corp. |
| 1569 W. 2650 S. |
| Suite 7 |
|
Ogden,
UT
84401
|
|
| Applicant Contact |
TED HILLSTEAD |
| Correspondent |
| U. S. A. Medical Corp. |
| 1569 W. 2650 S. |
| Suite 7 |
|
Ogden,
UT
84401
|
|
| Correspondent Contact |
TED HILLSTEAD |
| Regulation Number | 878.4780 |
| Classification Product Code |
|
| Date Received | 07/22/1986 |
| Decision Date | 08/04/1986 |
| Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
| 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
|