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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Case, Contact Lens
510(k) Number K840691
Device Name CONTACT LENS CASE FOR RIGID GAS PERMA
Applicant
Optimum Manufacturers, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Optimum Manufacturers, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number886.5928
Classification Product Code
LRX  
Date Received02/16/1984
Decision Date 05/18/1984
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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