FDA 510(k) Application Details - K060995

Device Classification Name Folders And Injectors, Intraocular Lens (Iol)

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510(K) Number K060995
Device Name Folders And Injectors, Intraocular Lens (Iol)
Applicant DUCKWORTH & KENT, LTD.
7 MARQUIS BUSINESS CENTRE
ROYSTON RD.
BALDOCK, HERTFORDSHIRE SG7 6XL GB
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Contact MARTIN LOCK
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Regulation Number 886.4300

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Classification Product Code MSS
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Date Received 04/11/2006
Decision Date 05/22/2006
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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