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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name keratoscope, ac-powered
510(k) Number K850665
Device Name CORNEASCOPE MODEL 1200
Applicant
KERA CORP.
2362 WALSH AVE.
SANTA CLARA,  CA  95051
Applicant Contact COLLINS
Correspondent
KERA CORP.
2362 WALSH AVE.
SANTA CLARA,  CA  95051
Correspondent Contact COLLINS
Regulation Number886.1350
Classification Product Code
HLQ  
Date Received02/20/1985
Decision Date 03/20/1985
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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