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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K822431
Device Name SUNGLASS & SAFETY PLANO LENS
Applicant
Polycore Optical Pte , Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Polycore Optical Pte , Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Date Received08/12/1982
Decision Date 12/27/1982
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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