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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
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