Device Classification Name |
needle, aspiration and injection, disposable
|
510(k) Number |
K925621 |
Device Name |
IRRIGATION/ASPIRATION TUBING SET |
Applicant |
KIRWAN SURGICAL PRODUCTS, INC. |
83 E. WATER ST. |
P.O. BOX 545 |
ROCKLAND,
MA
02370
|
|
Applicant Contact |
DANA A OLIVER |
Correspondent |
KIRWAN SURGICAL PRODUCTS, INC. |
83 E. WATER ST. |
P.O. BOX 545 |
ROCKLAND,
MA
02370
|
|
Correspondent Contact |
DANA A OLIVER |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 11/06/1992 |
Decision Date | 05/07/1993 |
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
|