The following data is part of a premarket notification filed by Novalung Gmbh with the FDA for Novalung Surgical Lung Assist (sla) Membrane Lung.
| Device ID | K072362 |
| 510k Number | K072362 |
| Device Name: | NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | NOVALUNG GMBH 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Rosina Robinson |
| Correspondent | Rosina Robinson NOVALUNG GMBH 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2007-08-22 |
| Decision Date | 2007-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260058550711 | K072362 | 000 |