The following data is part of a premarket notification filed by Nascor Pty. Ltd. with the FDA for Nascor Oxydome.
| Device ID | K905627 |
| 510k Number | K905627 |
| Device Name: | NASCOR OXYDOME |
| Classification | Tent, Oxygen |
| Applicant | NASCOR PTY. LTD. 7 WATSON ROAD PADSTOW, N.S.W.2211 Sydney, Australia, AU |
| Contact | Howard Chilton |
| Correspondent | Howard Chilton NASCOR PTY. LTD. 7 WATSON ROAD PADSTOW, N.S.W.2211 Sydney, Australia, AU |
| Product Code | BYL |
| CFR Regulation Number | 868.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-14 |
| Decision Date | 1991-06-03 |