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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 K831084
Device Name SUN PHOTO-KERATOSCOPE
Applicant
NIDEK, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
NIDEK, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number886.1350
Classification Product Code
HLQ  
Date Received04/04/1983
Decision Date 06/30/1983
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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