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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name keratome, ac-powered
510(k) Number K913697
Device Name AUTOMATIC CORNEAL SHAPER
Applicant
HANSA RESEARCH & DEVELOPMENT, INC.
7790 N.W. 55 ST.
MIAMI,  FL  33166
Applicant Contact BRIGITTA HELLENKAMP
Correspondent
HANSA RESEARCH & DEVELOPMENT, INC.
7790 N.W. 55 ST.
MIAMI,  FL  33166
Correspondent Contact BRIGITTA HELLENKAMP
Regulation Number886.4370
Classification Product Code
HNO  
Date Received08/19/1991
Decision Date 11/05/1991
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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