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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name microscope, operating & accessories, ac-powered, ophthalmic
510(k) Number K850270
Device Name CORNEAL LIGHT SHIELD
Applicant
MENTOR O & O, INC.
SOUTH SHORE PARK
HINGHAM,  MA  02043
Applicant Contact DAVID M LINK
Correspondent
MENTOR O & O, INC.
SOUTH SHORE PARK
HINGHAM,  MA  02043
Correspondent Contact DAVID M LINK
Regulation Number878.4700
Classification Product Code
HRM  
Date Received01/23/1985
Decision Date 05/31/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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