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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 K935251
Device Name MARTINEZ ORBITAL IMPLANT
Applicant
MIGUEL MARTINEZ M.D.
1880 W. SUNSET KNOLL LN.
TUCSON,  AZ  85704 -0949
Applicant Contact MIGUEL MARTINEZ
Correspondent
MIGUEL MARTINEZ M.D.
1880 W. SUNSET KNOLL LN.
TUCSON,  AZ  85704 -0949
Correspondent Contact MIGUEL MARTINEZ
Regulation Number886.3320
Classification Product Code
HPZ  
Date Received11/01/1993
Decision Date 03/01/1994
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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