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510(k) K011498

Device
EASY CONTROL MICRO INSERTER, MODEL ON385
Applicant
OPHTEC USA, INC.
510(k) number
K011498
Product code
NCE  
Decision
Substantially Equivalent (SESE)
Decision date
2001-07-09
Date received
2001-05-15
Regulation
886.4300
Classification name
Injector, Capsular Tension Ring
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RICK MCCARLEY
Address
6421 Congress Ave., Suite 112 Boca Raton FL US 33487 33487

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NCE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K042478CAPSULE TENSION RING INSERTER, MODEL 7-810Duckworth & Kent, Ltd.2004-12-28
K001125GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RINGGeuder GmbH2000-10-04

Legacy Summary#

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FDA Review#

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