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510(k) K001125

Device
GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING
Applicant
GEUDER GMBH
510(k) number
K001125
Product code
NCE  
Decision
Substantially Equivalent (SESE)
Decision date
2000-10-04
Date received
2000-04-07
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
HILLARD W WELCH
Address
344 Annabelle Pt. Rd. Centercille MA US 02632 02632

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
K042478CAPSULE TENSION RING INSERTER, MODEL 7-810Duckworth & Kent, Ltd.2004-12-28
K011498EASY CONTROL MICRO INSERTER, MODEL ON385Ophtec USA, Inc.2001-07-09

Legacy Summary#

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FDA Review#

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