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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 K982562
Device Name BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER
Applicant
Integrated Orbital Implants, Inc.
12526 High Bluff Dr.
Suite 300
San Diego,  CA  92130
Applicant Contact JEANNE DUNHAM
Correspondent
Integrated Orbital Implants, Inc.
12526 High Bluff Dr.
Suite 300
San Diego,  CA  92130
Correspondent Contact JEANNE DUNHAM
Regulation Number886.3320
Classification Product Code
HPZ  
Subsequent Product Code
HQN  
Date Received07/23/1998
Decision Date 12/28/1998
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
Recalls CDRH Recalls
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