FDA 510(k) Application Details - K040914

Device Classification Name Case, Contact Lens

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510(K) Number K040914
Device Name Case, Contact Lens
Applicant EXERO PRODUCTS, INC.
623 GLACIER DRIVE
GRAND JUNCTION, CO 81503 US
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Contact MARTIN DALSING
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Regulation Number 886.5928

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Classification Product Code LRX
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Date Received 04/08/2004
Decision Date 05/27/2004
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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