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FDA 510(k) Application Details - K010902
Device Classification Name
Implant, Eye Sphere
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510(K) Number
K010902
Device Name
Implant, Eye Sphere
Applicant
POREX SURGICAL, INC.
15 DART RD.
NEWNAN, GA 30265 US
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Contact
HOWARD MERCER
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Regulation Number
886.3320
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Classification Product Code
HPZ
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More FDA Info for this Product Code
Date Received
03/26/2001
Decision Date
06/19/2001
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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