Device Classification Name |
needle, aspiration and injection, disposable
|
510(k) Number |
K897050 |
Device Name |
WILSON-COOK LUNG BIOPSY NEEDLE |
Applicant |
WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION RD. & |
5951 GRASSY CREEK BLVD. |
WINSTON-SALEM,
NC
27105
|
|
Applicant Contact |
F MARSHALL |
Correspondent |
WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION RD. & |
5951 GRASSY CREEK BLVD. |
WINSTON-SALEM,
NC
27105
|
|
Correspondent Contact |
F MARSHALL |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 12/18/1989 |
Decision Date | 04/16/1990 |
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
|