Device Classification Name |
endoscopic video imaging system/component, gastroenterology-urology
|
510(k) Number |
K954734 |
Device Name |
THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM (MODIFICATION) |
Applicant |
THE TULIP MFG. CO. |
40 WEST BASELINE RD., |
SUITE 120 |
MESA,
AZ
85210
|
|
Applicant Contact |
RICHARD S HUNTER |
Correspondent |
THE TULIP MFG. CO. |
40 WEST BASELINE RD., |
SUITE 120 |
MESA,
AZ
85210
|
|
Correspondent Contact |
RICHARD S HUNTER |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 10/03/1995 |
Decision Date | 11/14/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|