Device Classification Name |
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
|
510(k) Number |
K903457 |
Device Name |
PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER) |
Applicant |
PRECISE OPTICS |
22 EAST BROADWAY |
GARDNER,
MA
01440
|
|
Applicant Contact |
FRANCIS L PUGSLEY |
Correspondent |
PRECISE OPTICS |
22 EAST BROADWAY |
GARDNER,
MA
01440
|
|
Correspondent Contact |
FRANCIS L PUGSLEY |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 08/01/1990 |
Decision Date | 10/19/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|