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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 K946054
Device Name DIPLOMAX
Applicant
OPTICAL MICRO SYSTEMS, INC.
300 WILLOW ST. SOUTH
NORTH ANDOVER,  MA  01845
Applicant Contact GERALD A CLAY
Correspondent
OPTICAL MICRO SYSTEMS, INC.
300 WILLOW ST. SOUTH
NORTH ANDOVER,  MA  01845
Correspondent Contact GERALD A CLAY
Regulation Number886.4670
Classification Product Code
HQC  
Date Received12/12/1994
Decision Date 07/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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