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FDA 510(k) Application Details - K972143
Device Classification Name
Implant, Eye Sphere
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510(K) Number
K972143
Device Name
Implant, Eye Sphere
Applicant
IOP, INC.
3100 AIRWAY AVE., SUITE 106
COSTA MESA, CA 92626 US
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Contact
JASON MALECKA
Other 510(k) Applications for this Contact
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
06/06/1997
Decision Date
10/16/1997
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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