Device Classification Name |
endoscopic injection needle, gastroenterology-urology
|
510(k) Number |
K941305 |
Device Name |
WILSON-COOK VARIABLE LENGTH GI INJECTION NEEDLE |
Applicant |
WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION RD. |
WINSTON-SALEM,
NC
27105
|
|
Applicant Contact |
PAULA JOYCE |
Correspondent |
WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION RD. |
WINSTON-SALEM,
NC
27105
|
|
Correspondent Contact |
PAULA JOYCE |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/17/1994 |
Decision Date | 06/02/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|