FDA 510(k) Application Details - K060151

Device Classification Name Expander, Tissue, Orbital

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510(K) Number K060151
Device Name Expander, Tissue, Orbital
Applicant INNOVIA, LLC
12415 SW 136 AVENUE
UNIT 3
MIAMI, FL 33186 US
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Contact STEWART B DAVIS
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Regulation Number 886.3320

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Classification Product Code NFM
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Date Received 01/20/2006
Decision Date 08/08/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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