FDA 510(k) Application Details - K170520

Device Classification Name Vitrectomy, Instrument Cutter

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510(K) Number K170520
Device Name Vitrectomy, Instrument Cutter
Applicant Alcon Research, Ltd.
20511 Lake Forest Drive
Lake Forest, CA 92630 US
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Contact Karen Mudd
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Regulation Number 886.4150

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Classification Product Code MLZ
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Date Received 02/22/2017
Decision Date 03/22/2017
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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