FDA 510(k) Application Details - K060366

Device Classification Name Unit, Phacofragmentation

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510(K) Number K060366
Device Name Unit, Phacofragmentation
Applicant ADVANCED MEDICAL OPTICS, INC.
1700 EAST ST. ANDREW PL.
MAIL STOP: SA-2J
SANTA ANA, CA 92799 US
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Contact TONI ELLIOTT
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Regulation Number 886.4670

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Classification Product Code HQC
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Date Received 02/13/2006
Decision Date 04/07/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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