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FDA 510(k) Application Details - K110554
Device Classification Name
Implant, Eye Sphere
More FDA Info for this Device
510(K) Number
K110554
Device Name
Implant, Eye Sphere
Applicant
CERAMISYS LTD.
344 ANNABELLE POINT ROAD
CENTERCILLE, MA 02632-2402 US
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Contact
HILLARD W WELCH
Other 510(k) Applications for this Contact
Regulation Number
886.3320
More FDA Info for this Regulation Number
Classification Product Code
HPZ
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More FDA Info for this Product Code
Date Received
02/28/2011
Decision Date
11/02/2011
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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