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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 K822315
Device Name GFB-B CONTACT LENS BLANKS
Applicant
Hamel, Park, Mccabe & Saunders
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Hamel, Park, Mccabe & Saunders
4221 Richmond Rd., NW
Walker,  MI  49534
Classification Product Code
HPX  
Date Received08/03/1982
Decision Date 11/16/1982
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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