FDA 510(k) Application Details - K083812

Device Classification Name Accessories, Soft Lens Products

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510(K) Number K083812
Device Name Accessories, Soft Lens Products
Applicant ALLERGAN, INC.
269A BALLARDVALE STREET
WILMINGTON, MA 01887 US
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Contact BEVERLEY D VENUTI
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Regulation Number 886.5928

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Classification Product Code LPN
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Date Received 12/22/2008
Decision Date 07/09/2009
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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