Device Classification Name |
laparoscope, general & plastic surgery
|
510(k) Number |
K143640 |
Device Name |
KSEA CMOS Camera System (C-cam) |
Applicant |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
2151 E. GRAND AVENUE |
EL SEGUNDO,
CA
90245
|
|
Applicant Contact |
Susie S Chen |
Correspondent |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
2151 E. GRAND AVENUE |
EL SEGUNDO,
CA
90245
|
|
Correspondent Contact |
Winkie Wong |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 12/22/2014 |
Decision Date | 09/17/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|