The following data is part of a premarket notification filed by Lazarus Medical Llc with the FDA for Phoneris Inner Cannulae With Phoneris Aero-flex Ventilator Circuit Connector.
| Device ID | K073702 |
| 510k Number | K073702 |
| Device Name: | PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | LAZARUS MEDICAL LLC 2129 BENEVENTUM CT Raleigh, NC 27606 |
| Contact | Cynthia J.m Nolte |
| Correspondent | Cynthia J.m Nolte LAZARUS MEDICAL LLC 2129 BENEVENTUM CT Raleigh, NC 27606 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-31 |
| Decision Date | 2008-06-26 |
| Summary: | summary |