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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 K831973
Device Name HARD CONTACT LENS CASE
Applicant
Moonbeam International, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Moonbeam International, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Classification Product Code
HPX  
Date Received06/20/1983
Decision Date 10/19/1983
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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