Device Classification Name |
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
|
510(k) Number |
K122505 |
Device Name |
SINGLE USE PRELOADED SPHINCTEROTOME V |
Applicant |
OLYMPUS MEDICAL SYSTEMS CORP. |
REGULATORY AFFAIRS & QUALITY ASSURANCE |
3500 CORPORATE PARKWAY |
CENTER VALLEY,
PA
18034 -0610
|
|
Applicant Contact |
SHERI MUSGNUNG |
Correspondent |
OLYMPUS MEDICAL SYSTEMS CORP. |
REGULATORY AFFAIRS & QUALITY ASSURANCE |
3500 CORPORATE PARKWAY |
CENTER VALLEY,
PA
18034 -0610
|
|
Correspondent Contact |
SHERI MUSGNUNG |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 08/16/2012 |
Decision Date | 04/11/2013 |
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
|
|
|