FDA 510(k) Application Details - K073023

Device Classification Name Unit, Phacofragmentation

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510(K) Number K073023
Device Name Unit, Phacofragmentation
Applicant BAUSCH & LOMB, INC.
1400 NORTH GOODMAN ST.
ROCHESTER, NY 14609-3547 US
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Contact NED LUCE
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Regulation Number 886.4670

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Classification Product Code HQC
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Date Received 10/26/2007
Decision Date 03/12/2008
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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