Device Classification Name |
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
|
510(k) Number |
K973252 |
Device Name |
KARL STORZ DIRECT COUPLED CAMERA HEAD |
Applicant |
KARL STORZ IMAGING, INC. |
175 CREMONA DR. |
GOLETA,
CA
93117
|
|
Applicant Contact |
TERRY FERNANDEZ |
Correspondent |
KARL STORZ IMAGING, INC. |
175 CREMONA DR. |
GOLETA,
CA
93117
|
|
Correspondent Contact |
TERRY FERNANDEZ |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 08/29/1997 |
Decision Date | 11/24/1997 |
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
|
|
|