Device Classification Name |
Lithotriptor, Electro-Hydraulic
|
510(k) Number |
K981233 |
Device Name |
KSEA CALCUSPLIT |
Applicant |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE |
CULVER CITY,
CA
90230 -7600
|
|
Applicant Contact |
KEVIN KENNAN |
Correspondent |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE |
CULVER CITY,
CA
90230 -7600
|
|
Correspondent Contact |
KEVIN KENNAN |
Regulation Number | 876.4480
|
Classification Product Code |
|
Date Received | 04/03/1998 |
Decision Date | 06/15/1998 |
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
|
|
|