Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K865079 |
Device Name |
ASPIRATING NEEDLE, CATALOG CODE #12006 |
Applicant |
DLP, INC. |
P.O.BOX 409 |
620 WATSONS S.W. |
GRAND RAPIDS,
MI
49501
|
|
Applicant Contact |
WILLIAMS, PHD |
Correspondent |
DLP, INC. |
P.O.BOX 409 |
620 WATSONS S.W. |
GRAND RAPIDS,
MI
49501
|
|
Correspondent Contact |
WILLIAMS, PHD |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 12/29/1986 |
Decision Date | 03/03/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|