The following data is part of a premarket notification filed by Dhd Medical Products Div. Diemolding Corp. with the FDA for Hoo2d Seat-infant.
| Device ID | K820640 |
| 510k Number | K820640 |
| Device Name: | HOO2D SEAT-INFANT |
| Classification | Tent, Oxygen |
| Applicant | DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BYL |
| CFR Regulation Number | 868.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-08 |
| Decision Date | 1982-03-26 |