Device Classification Name |
light source, endoscope, xenon arc
|
510(k) Number |
K022490 |
Device Name |
KSEA MEDI PACK |
Applicant |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE 5TH FLOOR |
CULVER CITY,
CA
90230 -7600
|
|
Applicant Contact |
JAMES A LEE |
Correspondent |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE 5TH FLOOR |
CULVER CITY,
CA
90230 -7600
|
|
Correspondent Contact |
JAMES A LEE |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/29/2002 |
Decision Date | 09/29/2003 |
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
|
|
|