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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K854169
Device Name PUPILSCAN
Applicant
Fairville Medical Optics, Inc.
Box 282
Montchanin,  DE  19710
Applicant Contact ANTHONY G SCOTT
Correspondent
Fairville Medical Optics, Inc.
Box 282
Montchanin,  DE  19710
Correspondent Contact ANTHONY G SCOTT
Date Received10/15/1985
Decision Date 12/16/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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