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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Keratome, Ac-Powered
510(k) Number K032910
Device Name CARRIAZO PENDULAR
Applicant
Schwind Eye-Tech-Solutions GmbH & Co. KG
23832 Via Monte
Coto De Caza,  CA  92679
Applicant Contact WILLIAM T KELLEY
Correspondent
Schwind Eye-Tech-Solutions GmbH & Co. KG
23832 Via Monte
Coto De Caza,  CA  92679
Correspondent Contact WILLIAM T KELLEY
Regulation Number886.4370
Classification Product Code
HNO  
Date Received09/22/2003
Decision Date 08/30/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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