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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Vitreous Aspiration And Cutting, Ac-Powered
510(k) Number K033390
Device Name COLIBRI DISPOSABLE VITRECTOMY CUTTER
Applicant
MICROWORLD MEDICAL INSTRUMENTS, INC.
4640 MALAT ST.
OAKLAND,  CA  94601
Applicant Contact SEMYON GAMBARIN
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
12 COMMERCE RD.
NEWTON,  CT  06470
Correspondent Contact HEINZ-JOERG STENEBERG
Regulation Number886.4150
Classification Product Code
HQE  
Date Received10/23/2003
Decision Date 11/04/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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