The following data is part of a premarket notification filed by Delta Medical Industries with the FDA for One-way Air Valve.
| Device ID | K840253 | 
| 510k Number | K840253 | 
| Device Name: | ONE-WAY AIR VALVE | 
| Classification | Trap, Sterile Specimen | 
| Applicant | DELTA MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 | 
| Product Code | BYZ | 
| CFR Regulation Number | 880.6740 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1984-01-23 | 
| Decision Date | 1984-04-05 |