Device Classification Name |
Cystourethroscope
|
510(k) Number |
K062918 |
Device Name |
KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM |
Applicant |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE |
5TH FLOOR |
CULVER CITY,
CA
90230 -7600
|
|
Applicant Contact |
SUSIE CHEN |
Correspondent |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE |
5TH FLOOR |
CULVER CITY,
CA
90230 -7600
|
|
Correspondent Contact |
SUSIE CHEN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/28/2006 |
Decision Date | 01/17/2007 |
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
|
|
|