FDA 510(k) Application Details - K050250

Device Classification Name Accessories, Soft Lens Products

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510(K) Number K050250
Device Name Accessories, Soft Lens Products
Applicant CIBA VISION CORPORATION
11460 JOHNS CREEK PARKWAY
DULUTH, GA 30097 US
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Contact STEVEN DOWDLEY
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Regulation Number 886.5928

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Classification Product Code LPN
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Date Received 02/03/2005
Decision Date 08/10/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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