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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 K946226
Device Name CUSTOM OCULAR PROSTHESIS
Applicant
Frank Tanaka, Ocularist, Inc.
3000 E. Fletcher Ave.,
Suite 310
Tampa,  FL  33613
Applicant Contact K F TANAKA
Correspondent
Frank Tanaka, Ocularist, Inc.
3000 E. Fletcher Ave.,
Suite 310
Tampa,  FL  33613
Correspondent Contact K F TANAKA
Regulation Number886.3200
Classification Product Code
HQH  
Date Received12/22/1994
Decision Date 03/22/1995
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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