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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biomicroscope, Slit-Lamp, Ac-Powered
510(k) Number K912514
Device Name TANDEM SCANNING MICROSCOPE
Applicant
Tandem Scanning Corp.
4903 Sangamore Rd.
Bethesda,  MD  20816
Applicant Contact DONALD L MACKEEN
Correspondent
Tandem Scanning Corp.
4903 Sangamore Rd.
Bethesda,  MD  20816
Correspondent Contact DONALD L MACKEEN
Regulation Number886.1850
Classification Product Code
HJO  
Date Received06/06/1991
Decision Date 12/16/1991
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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