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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Capsular Tension Ring
510(k) Number K001125
Device Name GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING
Applicant
Geuder GmbH
344 Annabelle Pt. Rd.
Centercille,  MA  02632
Applicant Contact HILLARD W WELCH
Correspondent
Geuder GmbH
344 Annabelle Pt. Rd.
Centercille,  MA  02632
Correspondent Contact HILLARD W WELCH
Regulation Number886.4300
Classification Product Code
NCE  
Date Received04/07/2000
Decision Date 10/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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