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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 K030891
Device Name SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK
Applicant
SURGISTAR, INC.
6068 CORTE DEL CEDRO
CARLSBAD,  CA  92009
Applicant Contact JONATHAN WOODWARD
Correspondent
SURGISTAR, INC.
6068 CORTE DEL CEDRO
CARLSBAD,  CA  92009
Correspondent Contact JONATHAN WOODWARD
Regulation Number886.4370
Classification Product Code
HNO  
Date Received03/21/2003
Decision Date 06/17/2003
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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