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FDA 510(k) Application Details - K010852
Device Classification Name
Expander, Tissue, Orbital
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510(K) Number
K010852
Device Name
Expander, Tissue, Orbital
Applicant
IOP, INC.
3151 AIRWAY AVE., BLDG. I-1
COSTA MESA, CA 92626 US
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Contact
JASON MALECKA
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Regulation Number
886.3320
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Classification Product Code
NFM
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More FDA Info for this Product Code
Date Received
03/21/2001
Decision Date
08/13/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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