Device Classification Name |
light source, endoscope, xenon arc
|
510(k) Number |
K934559 |
Device Name |
KARL STORZ XENON LIGHT SOURCE MODEL 201320-20 |
Applicant |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
10111 W. JEFFERSON BLVD. |
CULVER CITY,
CA
90232 -3578
|
|
Applicant Contact |
ROBERT R GIORGINI |
Correspondent |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
10111 W. JEFFERSON BLVD. |
CULVER CITY,
CA
90232 -3578
|
|
Correspondent Contact |
ROBERT R GIORGINI |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/16/1993 |
Decision Date | 04/22/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|