Device Classification Name |
Ureteroscope And Accessories, Flexible/Rigid
|
510(k) Number |
K982905 |
Device Name |
MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE |
Applicant |
KARL STORZ ENDOSCOPY |
600 CORPORATE POINTE |
CULVER CITY,
CA
90230 -7600
|
|
Applicant Contact |
KEVIN A KENNAN |
Correspondent |
Karl Storz Endoscopy- America, Inc. |
2151 East Grand Avenue |
El Segundo,
CA
90245
|
|
Correspondent Contact |
Leigh A Spotten |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 08/18/1998 |
Decision Date | 10/05/1998 |
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
|
Recalls |
CDRH Recalls
|
|
|