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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Eye Sphere
510(k) Number K082850
Device Name EYE SPHERES
Applicant
Product and Educational Services, LLC
3805 Old Easton Rd.
Doylestown,  PA  18902
Applicant Contact EDWARD GRIFFITH
Correspondent
Product and Educational Services, LLC
3805 Old Easton Rd.
Doylestown,  PA  18902
Correspondent Contact EDWARD GRIFFITH
Regulation Number886.3320
Classification Product Code
HPZ  
Date Received09/29/2008
Decision Date 02/27/2009
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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