FDA 510(k) Application Details - K110951

Device Classification Name Photocoagulator And Accessories

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510(K) Number K110951
Device Name Photocoagulator And Accessories
Applicant ALCON RESEARCH, LTD.
15800 ALTON PARKWAY
IRVINE, CA 92618 US
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Contact MARTIN A KAUFMAN
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Regulation Number 886.4690

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Classification Product Code HQB
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Date Received 04/04/2011
Decision Date 10/17/2011
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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