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510(k) K946226

CUSTOM OCULAR PROSTHESIS by Frank Tanaka, Ocularist, Inc. — Product Code HQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1995
Date Received
December 22, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Eye, Artificial, Non-Custom
Device Class
Class I
Regulation Number
886.3200
Review Panel
OP
Submission Type

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