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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Vitreous Aspiration And Cutting, Ac-Powered
510(k) Number K844715
Device Name VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY
Applicant
Optical Micro Systems, Inc.
8 Electronics Ave.
Danvers,  MA  01923
Applicant Contact WAYNE A RICHARD
Correspondent
Optical Micro Systems, Inc.
8 Electronics Ave.
Danvers,  MA  01923
Correspondent Contact WAYNE A RICHARD
Regulation Number886.4150
Classification Product Code
HQE  
Date Received11/27/1984
Decision Date 01/22/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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