FDA 510(k) Application Details - K090362

Device Classification Name Case, Contact Lens

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510(K) Number K090362
Device Name Case, Contact Lens
Applicant VOGUESTRAP
55 Northern Blvd
Suite 200
Great Neck, NY 11021 US
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Contact MARIA F GRIFFIN
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Regulation Number 886.5928

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Classification Product Code LRX
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Date Received 02/13/2009
Decision Date 02/27/2009
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 Y
Expedited Review



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