Device Classification Name |
needle, aspiration and injection, reusable
|
510(k) Number |
K885283 |
Device Name |
ASPIRATING AND IRRIGATING CYSTS NEEDLES |
Applicant |
GOMEDICAL INDUSTRIES PTY LTD. |
20, DENIS ST. |
SUBIACO 6008 |
WESTERN AUSTRALIA,
AU
|
|
Applicant Contact |
GEORGE O'NEIL |
Correspondent |
GOMEDICAL INDUSTRIES PTY LTD. |
20, DENIS ST. |
SUBIACO 6008 |
WESTERN AUSTRALIA,
AU
|
|
Correspondent Contact |
GEORGE O'NEIL |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 12/20/1988 |
Decision Date | 03/22/1989 |
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
|