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FDA 510(k) Application Details - K983797
Device Classification Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
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510(K) Number
K983797
Device Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Applicant
DUTCH OPHTHALMIC USA, INC.
ONE LITTLE RIVER RD.
KINGSTON, NH 03848 US
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Contact
MARK W FURLONG
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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
10/28/1998
Decision Date
03/03/1999
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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