Device Classification Name |
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
|
510(k) Number |
K851964 |
Device Name |
E.R.C.P.-1 ENDOSCOPIC RETROGRADE CHOLANGIO-CATHETE |
Applicant |
WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION RD. |
WINSTON-SALEM,
NC
27105
|
|
Applicant Contact |
JON WILSON |
Correspondent |
WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION RD. |
WINSTON-SALEM,
NC
27105
|
|
Correspondent Contact |
JON WILSON |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 05/03/1985 |
Decision Date | 06/13/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|