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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name biopsy needle
510(k) Number K050503
Device Name SINGLE USE ASPIRATION NEEDLE NA-201SX-4022
Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -9058
Applicant Contact LARUA STORMS-TYLER
Correspondent
OLYMPUS MEDICAL SYSTEMS CORPORATION
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -9058
Correspondent Contact LARUA STORMS-TYLER
Regulation Number876.1075
Classification Product Code
FCG  
Date Received02/28/2005
Decision Date 05/12/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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