Device Classification Name |
Image, Illumination, Fiberoptic, For Endoscope
|
510(k) Number |
K980636 |
Device Name |
FIBER OPTIC ENDOILLUMINATION PROBE |
Applicant |
DUTCH OPHTHALMIC USA, INC. |
ONE LITTLE RIVER RD. |
KINGSTON,
NH
03848
|
|
Applicant Contact |
MARK W FURLONG |
Correspondent |
DUTCH OPHTHALMIC USA, INC. |
ONE LITTLE RIVER RD. |
KINGSTON,
NH
03848
|
|
Correspondent Contact |
MARK W FURLONG |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 02/19/1998 |
Decision Date | 05/20/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|