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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
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