Device Classification Name |
Endoilluminator
|
510(k) Number |
K062259 |
FOIA Releasable 510(k) |
K062259
|
Device Name |
ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100 |
Applicant |
ISCIENCE SURGICAL |
4055 CAMPBELL AVENUE |
MENLO PARK,
CA
94025
|
|
Applicant Contact |
GRACE BARTOO |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
NEIL E DEVINE JR |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 08/04/2006 |
Decision Date | 08/15/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|