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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
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