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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, Battery-Powered
510(k) Number K890595
Device Name MENTOR ANTERIOR SEGMENT VITRECTOR
Applicant
Mentor O & O, Inc.
3000 Longwater Dr.
Norwell,  MA  02061 -1672
Applicant Contact MARK TOMA
Correspondent
Mentor O & O, Inc.
3000 Longwater Dr.
Norwell,  MA  02061 -1672
Correspondent Contact MARK TOMA
Regulation Number886.4150
Classification Product Code
HKP  
Date Received02/06/1989
Decision Date 04/17/1989
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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