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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 K080067
Device Name ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER
Applicant
ISCIENCE INTERVENTIONAL
4055 CAMPBELL AVENUE
MENLO PARK,  CA  94025
Applicant Contact GRACE BARTOO
Correspondent
ISCIENCE INTERVENTIONAL
4055 CAMPBELL AVENUE
MENLO PARK,  CA  94025
Correspondent Contact GRACE BARTOO
Regulation Number876.1500
Classification Product Code
MPA  
Subsequent Product Code
HMX  
Date Received01/10/2008
Decision Date 07/18/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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