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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Phacoemulsification, Reprocessed
510(k) Number K012579
Device Name REPROCESSED PHACO TIPS
Applicant
Sterilmed, Inc.
11400 73rd Ave. N Suite 100
Maple Grove,  MN  55369
Applicant Contact PATRICK FLEISCHHACKER
Correspondent
Sterilmed, Inc.
11400 73rd Ave. N Suite 100
Maple Grove,  MN  55369
Correspondent Contact PATRICK FLEISCHHACKER
Regulation Number886.4670
Classification Product Code
NKX  
Date Received08/09/2001
Decision Date 11/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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