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FDA 510(k) Application Details - K053176
Device Classification Name
Folders And Injectors, Intraocular Lens (Iol)
More FDA Info for this Device
510(K) Number
K053176
Device Name
Folders And Injectors, Intraocular Lens (Iol)
Applicant
DUCKWORTH & KENT, LTD.
7 MARQUIS BUSINESS CENTRE
ROYSTON RD.
BALDOCK, HERTSFORDSHIRE SG7 6XL GB
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MARTIN LOCK
Other 510(k) Applications for this Contact
Regulation Number
886.4300
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Classification Product Code
MSS
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More FDA Info for this Product Code
Date Received
11/14/2005
Decision Date
01/30/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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