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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 K953959
Device Name PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT TO PHACO HANDPIECES
Applicant
Microsurgical Technology, Inc.
P.O. Box 2679
8415 154th Ave. NE
Redmond,  WA  98052
Applicant Contact ED TERPILOWSKI
Correspondent
Microsurgical Technology, Inc.
P.O. Box 2679
8415 154th Ave. NE
Redmond,  WA  98052
Correspondent Contact ED TERPILOWSKI
Regulation Number886.4670
Classification Product Code
HQC  
Date Received08/22/1995
Decision Date 11/17/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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