The following data is part of a premarket notification filed by Manner Medical Products with the FDA for Maska, Oxygen Vinyl D-sp. Single Use.
| Device ID | K760219 |
| 510k Number | K760219 |
| Device Name: | MASKA, OXYGEN VINYL D-SP. SINGLE USE |
| Classification | Mask, Oxygen |
| Applicant | MANNER MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BYG |
| CFR Regulation Number | 868.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-07-12 |
| Decision Date | 1976-08-03 |