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510(k) K042478

Device
CAPSULE TENSION RING INSERTER, MODEL 7-810
Applicant
DUCKWORTH & KENT, LTD.
510(k) number
K042478
Product code
NCE  
Decision
Substantially Equivalent (SESE)
Decision date
2004-12-28
Date received
2004-09-13
Regulation
886.4300
Classification name
Injector, Capsular Tension Ring
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
MARTIN LOCK
Address
7 Marquis Business Centre Royston Rd. Baldock, Hertfordshire GB SG7 6XL SG7 6XL

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NCE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K011498EASY CONTROL MICRO INSERTER, MODEL ON385Ophtec USA, Inc.2001-07-09
K001125GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RINGGeuder GmbH2000-10-04

Legacy Summary#

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FDA Review#

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