FDA 510(k) Application Details - K141091

Device Classification Name Folders And Injectors, Intraocular Lens (Iol)

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510(K) Number K141091
Device Name Folders And Injectors, Intraocular Lens (Iol)
Applicant RAYNER INTRAOCULAR LENSES LTD.
1-2 SACKVILLE TRADING ESTATE,
SACKVILLE ROAD
HOVE, EAST SUSSEX BN3 7AN GB
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Contact JULIETTE COOK
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Regulation Number 886.4300

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Classification Product Code MSS
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Date Received 04/28/2014
Decision Date 05/28/2014
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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