FDA 510(k) Application Details - K042478

Device Classification Name Injector, Capsular Tension Ring

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510(K) Number K042478
Device Name Injector, Capsular Tension Ring
Applicant DUCKWORTH & KENT, LTD.
7 MARQUIS BUSINESS CENTRE
ROYSTON RD.
BALDOCK, HERTSFORDSHIRE 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 NCE
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Date Received 09/13/2004
Decision Date 12/28/2004
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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