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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Eye, Artificial, Non-Custom
510(k) Number K945270
Device Name CUSTOM ARTIFICIAL HUMAN EYES
Applicant
Daniel T Acosta
2244 Fourth Ave., Suite E
San Diego,  CA  92101
Applicant Contact DANIEL T ACOSTA
Correspondent
Daniel T Acosta
2244 Fourth Ave., Suite E
San Diego,  CA  92101
Correspondent Contact DANIEL T ACOSTA
Regulation Number886.3200
Classification Product Code
HQH  
Date Received10/28/1994
Decision Date 05/30/1995
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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