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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, phacofragmentation
510(k) Number K051186
Device Name MICROPULSE PHACOEMULSIFICATION SYSTEM
Applicant
TRILLIUM MEDICAL, INC.
P.O. BOX 2601
POULSBO,  WA  98370
Applicant Contact MICHAEL H CURTIS
Correspondent
TRILLIUM MEDICAL, INC.
P.O. BOX 2601
POULSBO,  WA  98370
Correspondent Contact MICHAEL H CURTIS
Regulation Number886.4670
Classification Product Code
HQC  
Date Received05/09/2005
Decision Date 08/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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