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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 K890622
Device Name SURG-E-TROL SYSTEM I AND SYSTEM II
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
HQE  
Date Received02/07/1989
Decision Date 05/04/1989
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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