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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K854140
Device Name MODIFIED MYDRIATIC SPECTACLE
Applicant
La Rue Optical
Industrial Park
P.O. Box 100
Dover,  PA  17315
Applicant Contact LA PRAIRIE
Correspondent
La Rue Optical
Industrial Park
P.O. Box 100
Dover,  PA  17315
Correspondent Contact LA PRAIRIE
Date Received10/10/1985
Decision Date 12/17/1985
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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