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FDA 510(k) Application Details - K143307
Device Classification Name
Folders And Injectors, Intraocular Lens (Iol)
More FDA Info for this Device
510(K) Number
K143307
Device Name
Folders And Injectors, Intraocular Lens (Iol)
Applicant
RAYNER INTRAOCULAR LENSES LTD.
1-2 SACKVILLE TRADING ESTATE,
SACKVILLE ROAD
HOVE BN3 7AN GB
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Contact
Juliette Cook
Other 510(k) Applications for this Contact
Regulation Number
886.4300
More FDA Info for this Regulation Number
Classification Product Code
MSS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/18/2014
Decision Date
12/18/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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