FDA 510(k) Application Details - K073060

Device Classification Name Lens, Contact, (Disposable)

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510(K) Number K073060
Device Name Lens, Contact, (Disposable)
Applicant INNOVA VISION INC.
2904 N. BOLDT DRIVE
FLAGGSTAFF, AZ 86001 US
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Contact JENNIFER REICH
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Regulation Number 886.5925

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Classification Product Code MVN
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Date Received 10/30/2007
Decision Date 11/29/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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