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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 K030179
Device Name MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES
Applicant
Surgical Instruments Service and Savings, Inc.
723 Curtis Ct; P.O. Box 2060
Sisters,  OR  97759
Applicant Contact MARY ANN BARKER
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607 -9526
Correspondent Contact CHARLES F MACK
Regulation Number886.4670
Classification Product Code
NKX  
Date Received01/17/2003
Decision Date 01/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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