The following data is part of a premarket notification filed by Ipax, Inc. with the FDA for Surebreath Dome.
| Device ID | K884076 |
| 510k Number | K884076 |
| Device Name: | SUREBREATH DOME |
| Classification | Retractor |
| Applicant | IPAX, INC. 2109 WEST AMHERST AVE. Englewood, CO 80110 |
| Contact | Pennell |
| Correspondent | Pennell IPAX, INC. 2109 WEST AMHERST AVE. Englewood, CO 80110 |
| Product Code | GAD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-27 |
| Decision Date | 1988-10-07 |