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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 K944616
Device Name KERATRON CORNEAL TOPOGRAPHER
Applicant
ALLIANCE MEDICAL MARKETINIG
3948 SOUTH THIRD ST. #282
JACKSONVILLE BEACH,  FL  32250
Applicant Contact SCOTT LEWIS
Correspondent
ALLIANCE MEDICAL MARKETINIG
3948 SOUTH THIRD ST. #282
JACKSONVILLE BEACH,  FL  32250
Correspondent Contact SCOTT LEWIS
Regulation Number886.1350
Classification Product Code
HLQ  
Date Received09/20/1994
Decision Date 11/22/1994
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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