FDA 510(k) Application Details - K070628

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

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510(K) Number K070628
Device Name Lens, Contact (Other Material) - Daily
Applicant CONTAMAC LTD.
2214 SANFORD DRIVE,SUITE B7
GRAND JUNCTION, CO 81505 US
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Contact MARTIN DALSING
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Regulation Number 886.5916

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Classification Product Code HQD
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Date Received 03/07/2007
Decision Date 05/01/2007
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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