Device Classification Name |
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
|
510(k) Number |
K972674 |
Device Name |
WILSON-COOK NEEDLE KNIFE PAPILLOTOME |
Applicant |
WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION RD. |
WINSTON-SALEM,
NC
27105
|
|
Applicant Contact |
LINDA HENSLEY |
Correspondent |
WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION RD. |
WINSTON-SALEM,
NC
27105
|
|
Correspondent Contact |
LINDA HENSLEY |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 07/16/1997 |
Decision Date | 08/15/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|