FDA 510(k) Application Details - K042578

Device Classification Name Case, Contact Lens

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510(K) Number K042578
Device Name Case, Contact Lens
Applicant I-PROMOTIONS, INC.
9522 GRAVOIS RD.
ST. LOUIS, MO 63123 US
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Contact CHARLOTTE SLANKARD
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Regulation Number 886.5928

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Classification Product Code LRX
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Date Received 09/22/2004
Decision Date 01/25/2005
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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