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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 K891137
Device Name MOTILITY ORBITAL IMPLANT
Applicant
Integrated Orbital Implants, Inc.
9834 Genesee Ave.
Suite 315
La Jolla,  CA  92037
Applicant Contact PERRY, M.D.
Correspondent
Integrated Orbital Implants, Inc.
9834 Genesee Ave.
Suite 315
La Jolla,  CA  92037
Correspondent Contact PERRY, M.D.
Regulation Number886.3320
Classification Product Code
HPZ  
Date Received03/03/1989
Decision Date 08/24/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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