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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lenses, Soft Contact, Daily Wear
510(k) Number K013445
Device Name OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES
Applicant
Florida Optical Engineering, Inc.
13709 Progress Blvd., Box 14
Alachua,  FL  32615
Applicant Contact RICHARD A GRIFFIN
Correspondent
Florida Optical Engineering, Inc.
13709 Progress Blvd., Box 14
Alachua,  FL  32615
Correspondent Contact RICHARD A GRIFFIN
Regulation Number886.5925
Classification Product Code
LPL  
Date Received10/17/2001
Decision Date 12/26/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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