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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biomicroscope, Slit-Lamp, Ac-Powered
510(k) Number K092883
Device Name LED LAMP OR OTHER
Applicant
Intravista Medical Systems, Inc.
1567 Samedra St.
Sunnyvale,  CA  94087
Applicant Contact WEI SU
Correspondent
Intravista Medical Systems, Inc.
1567 Samedra St.
Sunnyvale,  CA  94087
Correspondent Contact WEI SU
Regulation Number886.1850
Classification Product Code
HJO  
Date Received09/18/2009
Decision Date 12/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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