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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Table, Instrument, Manual, Ophthalmic
510(k) Number K760697
Device Name EVANS ARM AND HAND REST
Applicant
Alcon Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Alcon Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number886.4855
Classification Product Code
HRK  
Date Received09/22/1976
Decision Date 11/02/1976
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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