Device Classification Name |
laparoscope, general & plastic surgery
|
510(k) Number |
K060085 |
Device Name |
STRYKER SCOPE/INSTRUMENT HOLDER |
Applicant |
Stryker Endoscopy |
5900 OPTICAL CT. |
SAN JOSE,
CA
95138
|
|
Applicant Contact |
CRYSTAL ONG |
Correspondent |
Stryker Endoscopy |
5900 OPTICAL CT. |
SAN JOSE,
CA
95138
|
|
Correspondent Contact |
CRYSTAL ONG |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 01/11/2006 |
Decision Date | 04/27/2006 |
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
|