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FDA 510(k) Application Details - K120170
Device Classification Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
More FDA Info for this Device
510(K) Number
K120170
Device Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Applicant
VISIONCARE DEVICES, INC.
1246 REDWOOD BLVD.
REDDING, CA 96003 US
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Contact
KURTIS MONTEGNA
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
01/19/2012
Decision Date
05/30/2012
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
N
Expedited Review
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