| 510(k) Number |
K861878 |
| Device Name |
BYRON SUCTION TIPS |
| Applicant |
| Byron Medical |
| 3280 E. Hemisphere Loop |
| Suite 100 |
|
Tucson,
AZ
85706
|
|
| Applicant Contact |
FRED CHAPEL |
| Correspondent |
| Byron Medical |
| 3280 E. Hemisphere Loop |
| Suite 100 |
|
Tucson,
AZ
85706
|
|
| Correspondent Contact |
FRED CHAPEL |
| Date Received | 05/15/1986 |
| Decision Date | 07/01/1986 |
| Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|