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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, aspiration and injection, reusable
510(k) Number K895594
Device Name SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE
Applicant
GO MEDICAL INDUSTRIES PTY. LTD.
200 CHURCHILL AVE.
SUBIACO, PERTH,  AU 6008
Applicant Contact AGB O'NEIL
Correspondent
GO MEDICAL INDUSTRIES PTY. LTD.
200 CHURCHILL AVE.
SUBIACO, PERTH,  AU 6008
Correspondent Contact AGB O'NEIL
Regulation Number878.4800
Classification Product Code
GDM  
Date Received09/15/1989
Decision Date 10/06/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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