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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Irrigation, Ocular Surgery
510(k) Number K935003
Device Name ELECTRIC I/V POLE OR EIVP2
Applicant
Optical Micro Systems, Inc.
300 Willow St. S.
North Andover,  MA  01845
Applicant Contact RONALD LUICH
Correspondent
Optical Micro Systems, Inc.
300 Willow St. S.
North Andover,  MA  01845
Correspondent Contact RONALD LUICH
Regulation Number886.4360
Classification Product Code
KYG  
Date Received10/19/1993
Decision Date 01/25/1994
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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