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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy, Suction
510(k) Number K062159
Device Name RB12 SUCTION RECTAL BIOPSY SYSTEM
Applicant
Aus Systems Pty , Ltd.
2454 Mcmullen Booth Rd.
Suite 427
Clearwater,  FL  33759
Applicant Contact IAN P GORDON
Correspondent
Aus Systems Pty , Ltd.
2454 Mcmullen Booth Rd.
Suite 427
Clearwater,  FL  33759
Correspondent Contact IAN P GORDON
Regulation Number876.1075
Classification Product Code
FCK  
Date Received07/28/2006
Decision Date 09/05/2006
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
Predetermined Change
Control Plan Authorized		 No
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