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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Ave.
Menlo Park,  CA  94025
Applicant Contact GRACE BARTOO
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact NEIL E DEVINE JR
Regulation Number876.1500
Classification Product Code
MPA  
Date Received08/04/2006
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
Predetermined Change
Control Plan Authorized		 No
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