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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Contact (Polymethylmethacrylate)
510(k) Number K862811
Device Name AQUALUX LENS CASE
Applicant
Safeway Products, Inc.
440 Middlefield St.
Middletown,  CT  06457
Applicant Contact JACK HOWIE
Correspondent
Safeway Products, Inc.
440 Middlefield St.
Middletown,  CT  06457
Correspondent Contact JACK HOWIE
Classification Product Code
HPX  
Date Received07/24/1986
Decision Date 09/03/1986
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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