The following data is part of a premarket notification filed by Landmark Plastics with the FDA for Adapter, Per-cen-tox-body.
| Device ID | K760518 |
| 510k Number | K760518 |
| Device Name: | ADAPTER, PER-CEN-TOX-BODY |
| Classification | Mask, Oxygen, Low Concentration, Venturi |
| Applicant | LANDMARK PLASTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BYF |
| CFR Regulation Number | 868.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-08-26 |
| Decision Date | 1976-09-03 |