FDA 510(k) Application Details - K011914

Device Classification Name Lens, Contact (Other Material) - Daily

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510(K) Number K011914
Device Name Lens, Contact (Other Material) - Daily
Applicant INNOVISION, INC.
3125 SOUTH 61ST AVE.
OMAHA, NE 68106-3675 US
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Contact DON M WOODFORD
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Regulation Number 886.5916

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Classification Product Code HQD
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Date Received 06/19/2001
Decision Date 07/27/2001
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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