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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 K041108
Device Name ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA
Applicant
Iscience Surgical Corporation
2 Delphinus
Irvine,  CA  92612
Applicant Contact JUDY F GORDON
Correspondent
Iscience Surgical Corporation
2 Delphinus
Irvine,  CA  92612
Correspondent Contact JUDY F GORDON
Regulation Number876.1500
Classification Product Code
MPA  
Date Received04/28/2004
Decision Date 06/22/2004
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
Predetermined Change
Control Plan Authorized		 No
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