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FDA 510(k) Application Details - K033390
Device Classification Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
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510(K) Number
K033390
Device Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Applicant
MICROWORLD MEDICAL INSTRUMENTS, INC.
4640 MALAT ST.
OAKLAND, CA 94601 US
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Contact
SEMYON GAMBARIN
Other 510(k) Applications for this Contact
Regulation Number
886.4150
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Classification Product Code
HQE
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More FDA Info for this Product Code
Date Received
10/23/2003
Decision Date
11/04/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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