The following data is part of a premarket notification filed by Dentsleeve Pty., Ltd. with the FDA for Mark Ii Co2 Flush Manometric Perfusion Pump & Mark Ii Manometric Perfusion Pump.
| Device ID | K980946 |
| 510k Number | K980946 |
| Device Name: | MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | DENTSLEEVE PTY., LTD. 56 A/B GLEN OSMOND RD. Parkside South Australia, AU 5063 |
| Contact | Marcus Tippett |
| Correspondent | Marcus Tippett DENTSLEEVE PTY., LTD. 56 A/B GLEN OSMOND RD. Parkside South Australia, AU 5063 |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-13 |
| Decision Date | 1998-06-08 |
| Summary: | summary |