Device Classification Name |
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
|
510(k) Number |
K171993 |
Device Name |
Zimmon Needle Knife Papillotome |
Applicant |
Wilson-Cook Medical, Inc. / Cook Endoscopy |
4900 Bethania Station Road |
Winston-Salem,
NC
27105
|
|
Applicant Contact |
Doris A. Hawks |
Correspondent |
Wilson-Cook Medical, Inc. / Cook Endoscopy |
4900 Bethania Station Road |
Winston-Salem,
NC
27105
|
|
Correspondent Contact |
Doris A. Hawks |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 07/03/2017 |
Decision Date | 08/17/2017 |
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
|
|
|