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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 K864343
Device Name BL1 (HARD CONTACT LENS)
Applicant
Beta Labs, Inc.
42 Pleasant St.
Stoneham,  MA  02180
Applicant Contact ROBERT PAINTER
Correspondent
Beta Labs, Inc.
42 Pleasant St.
Stoneham,  MA  02180
Correspondent Contact ROBERT PAINTER
Classification Product Code
HPX  
Date Received11/04/1986
Decision Date 11/28/1986
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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