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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name grid, amsler
510(k) Number K843227
Device Name MACULAR FUNCTION ANALYZER
Applicant
DANEK MEDICAL, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
DANEK MEDICAL, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number886.1330
Classification Product Code
HOQ  
Date Received08/16/1984
Decision Date 07/22/1985
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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