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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Measuring, Corneal Radius
510(k) Number K864369
Device Name LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNER
Applicant
Heidelberg Instruments
Univ. Of California, San Diego
Dept. Of Ophthalmology (T-014)
La Jolla,  CA  92093
Applicant Contact STUART I BROWN
Correspondent
Heidelberg Instruments
Univ. Of California, San Diego
Dept. Of Ophthalmology (T-014)
La Jolla,  CA  92093
Correspondent Contact STUART I BROWN
Regulation Number886.1450
Classification Product Code
HJB  
Date Received11/05/1986
Decision Date 12/15/1986
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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