The following data is part of a premarket notification filed by Dhd Medical Products Div. Diemolding Corp. with the FDA for 45degrees Swivel Elbow.
| Device ID | K811922 |
| 510k Number | K811922 |
| Device Name: | 45DEGREES SWIVEL ELBOW |
| Classification | Connector, Airway (extension) |
| Applicant | DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZA |
| CFR Regulation Number | 868.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-02 |
| Decision Date | 1981-07-23 |