FDA 510(k) Application Details - K052832

Device Classification Name Lens, Contact, (Disposable)

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510(K) Number K052832
Device Name Lens, Contact, (Disposable)
Applicant SAUFLON PHARMACEUTICALS, LTD.
49-53 YORK ST.
TWICKENHAM, MIDDLESEX TW1-3LP GB
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Contact TANYA FAIR
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Regulation Number 886.5925

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Classification Product Code MVN
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Date Received 10/06/2005
Decision Date 05/15/2006
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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