Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K081995 |
Device Name |
STRYKER VISION ELECT WHDTV (STRYKER VE WHDTV) |
Applicant |
Stryker Endoscopy |
5900 OPTICAL CT. |
SAN JOSE,
CA
95138
|
|
Applicant Contact |
MONICA BARRETT |
Correspondent |
Stryker Endoscopy |
5900 OPTICAL CT. |
SAN JOSE,
CA
95138
|
|
Correspondent Contact |
MONICA BARRETT |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 07/14/2008 |
Decision Date | 10/02/2008 |
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
|