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 Number | 876.1075
|
Classification Product Code |
|
Date Received | 07/28/2006 |
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
|
|
|