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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 K885283
Device Name ASPIRATING AND IRRIGATING CYSTS NEEDLES
Applicant
Go Medical Industries Pty. , Ltd.
20, Denis St.
Subiaco 6008
Western Australia,  AU
Applicant Contact GEORGE O'NEIL
Correspondent
Go Medical Industries Pty. , Ltd.
20, Denis St.
Subiaco 6008
Western Australia,  AU
Correspondent Contact GEORGE O'NEIL
Regulation Number878.4800
Classification Product Code
GDM  
Date Received12/20/1988
Decision Date 03/22/1989
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
Predetermined Change
Control Plan Authorized		 No
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