FDA 510(k) Application Details - K051186

Device Classification Name Unit, Phacofragmentation

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510(K) Number K051186
Device Name Unit, Phacofragmentation
Applicant TRILLIUM MEDICAL, INC.
P.O. BOX 2601
POULSBO, WA 98370 US
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Contact MICHAEL H CURTIS
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Regulation Number 886.4670

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Classification Product Code HQC
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Date Received 05/09/2005
Decision Date 08/18/2005
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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