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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Refractometer, Ophthalmic
510(k) Number K802029
Device Name OBJECTIVE REFRACTOR
Applicant
Zeiss Humphrey System
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Zeiss Humphrey System
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number886.1760
Classification Product Code
HKO  
Date Received08/21/1980
Decision Date 11/12/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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