The following data is part of a premarket notification filed by Rollins Medical Solutions, Inc. with the FDA for Rollins 7 Oxygen Mask.
| Device ID | K130379 |
| 510k Number | K130379 |
| Device Name: | ROLLINS 7 OXYGEN MASK |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | ROLLINS MEDICAL SOLUTIONS, INC. 1468 HARWELL AVE. Crofton, MD 21114 |
| Contact | E. J Smith |
| Correspondent | E. J Smith ROLLINS MEDICAL SOLUTIONS, INC. 1468 HARWELL AVE. Crofton, MD 21114 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-14 |
| Decision Date | 2013-10-09 |
| Summary: | summary |