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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 K833903
Device Name BENZETHONIUM CHLORIDE
Applicant
Blairex Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Blairex Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Classification Product Code
HPX  
Date Received11/14/1983
Decision Date 05/30/1984
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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