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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Locator, Metal, Electronic
510(k) Number K781892
FOIA Releasable 510(k) K781892
Device Name LOCATOR, FOREIGN BODY
Applicant
Keeler Optical Products , Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Keeler Optical Products , Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number886.4400
Classification Product Code
HPM  
Date Received11/08/1978
Decision Date 12/04/1978
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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