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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 K912130
Device Name TBD KERATOSCOPE
Applicant
ALCON LABORATORIES
6201 SOUTH FREEWAY
R7-14
FORT WORTH,  TX  76134 -2099
Applicant Contact DAVID KRAPF
Correspondent
ALCON LABORATORIES
6201 SOUTH FREEWAY
R7-14
FORT WORTH,  TX  76134 -2099
Correspondent Contact DAVID KRAPF
Regulation Number886.1350
Classification Product Code
HLQ  
Date Received05/14/1991
Decision Date 08/09/1991
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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