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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 K014000
Device Name VISTITOME 20-10 MICROKERATOME
Applicant
BIOVISION AG
27 MAUCHLY, UNIT 206
IRVINE,  CA  92618
Applicant Contact DAVID S FERNQUIST
Correspondent
BIOVISION AG
27 MAUCHLY, UNIT 206
IRVINE,  CA  92618
Correspondent Contact DAVID S FERNQUIST
Regulation Number886.4370
Classification Product Code
HNO  
Date Received12/04/2001
Decision Date 03/11/2002
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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