FDA 510(k) Application Details - K090439

Device Classification Name System, Image Management, Ophthalmic

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510(K) Number K090439
Device Name System, Image Management, Ophthalmic
Applicant CARL ZEISS MEDITEC, INC.
5160 HACIENDA DRIVE
DUBLIN, CA 94568 US
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Contact KENT W JONES
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Regulation Number 892.2050

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Classification Product Code NFJ
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Date Received 02/20/2009
Decision Date 03/25/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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