Device Classification Name |
Light, Surgical, Floor Standing
|
510(k) Number |
K961971 |
Device Name |
Q-5000 |
Applicant |
Stryker Endoscopy |
2590 WALSH AVE. |
SANTA CLARA,
CA
95051 -4085
|
|
Applicant Contact |
BADER-E BELLAHSENE, PH.D. |
Correspondent |
Stryker Endoscopy |
2590 WALSH AVE. |
SANTA CLARA,
CA
95051 -4085
|
|
Correspondent Contact |
BADER-E BELLAHSENE, PH.D. |
Regulation Number | 878.4580
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/20/1996 |
Decision Date | 06/28/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|