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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Phacofragmentation
510(k) Number K844373
Device Name O.M.S. ULTRA-PHACO
Applicant
Optical Micro Systems, Inc.
8 Electronics Ave.
Danvers,  MA  01923
Applicant Contact GERALD A CLAY
Correspondent
Optical Micro Systems, Inc.
8 Electronics Ave.
Danvers,  MA  01923
Correspondent Contact GERALD A CLAY
Regulation Number886.4670
Classification Product Code
HQC  
Date Received11/13/1984
Decision Date 12/19/1985
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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