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FDA 510(k) Application Details - K091507
Device Classification Name
Folders And Injectors, Intraocular Lens (Iol)
More FDA Info for this Device
510(K) Number
K091507
Device Name
Folders And Injectors, Intraocular Lens (Iol)
Applicant
RAYNER INTRAOCULAR LENSES LTD.
SACKVILLE RD.
HOVE, EAST SUSSEX BN3 7AN GB
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Contact
ROYNAN H KERNAGHAN
Other 510(k) Applications for this Contact
Regulation Number
886.4300
More FDA Info for this Regulation Number
Classification Product Code
MSS
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More FDA Info for this Product Code
Date Received
05/21/2009
Decision Date
12/04/2009
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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