The following data is part of a premarket notification filed by Aus Systems Pty Ltd. with the FDA for Rb12 Suction Rectal Biopsy System.
| Device ID | K062159 |
| 510k Number | K062159 |
| Device Name: | RB12 SUCTION RECTAL BIOPSY SYSTEM |
| Classification | Instrument, Biopsy, Suction |
| Applicant | AUS SYSTEMS PTY LTD. 2454 MCMULLEN BOOTH RD. SUITE 427 Clearwater, FL 33759 |
| Contact | Ian P Gordon |
| Correspondent | Ian P Gordon AUS SYSTEMS PTY LTD. 2454 MCMULLEN BOOTH RD. SUITE 427 Clearwater, FL 33759 |
| Product Code | FCK |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-28 |
| Decision Date | 2006-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| CP12002 | K062159 | 000 |
| CP12001 | K062159 | 000 |
| CP12000 | K062159 | 000 |
| B194SS10001 | K062159 | 000 |