The following data is part of a premarket notification filed by Dentsleeve Pty., Ltd. with the FDA for Mark Ii/mark Iii Manometric Perfusion Pump.
| Device ID | K013154 |
| 510k Number | K013154 |
| Device Name: | MARK II/MARK III MANOMETRIC PERFUSION PUMP |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | DENTSLEEVE PTY., LTD. 13605 WEST 7TH AVE. Golden, CO 80401 -4604 |
| Contact | Robert N Clark |
| Correspondent | Robert N Clark DENTSLEEVE PTY., LTD. 13605 WEST 7TH AVE. Golden, CO 80401 -4604 |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-20 |
| Decision Date | 2001-10-19 |
| Summary: | summary |