FDA 510(k) Application Details - K130331

Device Classification Name Lens, Contact, (Disposable)

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510(K) Number K130331
Device Name Lens, Contact, (Disposable)
Applicant SAUFLON PHARMACEUTICALS, LTD.
49-53 YORK ST.
TWICKENHAM, MIDDLESEX TW1-3LP GB
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Contact CHRISTOPHER SMEJKAL
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Regulation Number 886.5925

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Classification Product Code MVN
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Date Received 02/11/2013
Decision Date 07/26/2013
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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