Device Classification Name |
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
|
510(k) Number |
K141991 |
Device Name |
SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP |
Applicant |
OLYMPUS MEDICAL SYSTEMS COPR. |
3500 CORPORATE PARKWAY |
PO BOX 610 |
CENTER VALLEY,
PA
18034 -0610
|
|
Applicant Contact |
DAPHNEY GERMAIN-KOLAWOLE |
Correspondent |
OLYMPUS MEDICAL SYSTEMS COPR. |
3500 CORPORATE PARKWAY |
PO BOX 610 |
CENTER VALLEY,
PA
18034 -0610
|
|
Correspondent Contact |
DAPHNEY GERMAIN-KOLAWOLE |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 07/22/2014 |
Decision Date | 03/31/2015 |
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
|
|
|